Iodine-alcohol preparation · Open-fracture surgical-site infection — Evidence Check

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Efficacy comparison · Preserved-material preparationIs the selected subclaim reduced infection after open-fracture fixation?Required	The preserved subclaim is reduced SSI after open-fracture fixation, originally graded D, with a note that the separate population was null at P=0.45. Parent B with 76 points and axes concern closed fractures. The selected row has no score, status or axes in the summary. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Distinction between original selected question, subclaim grade/note and parent verdict	Present the original records so the user can read the subclaim separately from parent context
2	Partly verified	Full text not readStored summary read	N02 · Efficacy comparison · Preserved-material preparationCan the positive closed-fracture result be applied to open fractures?Required	The preserved summary distinguishes closed and open fractures as separate prespecified populations. It records a null open-fracture result and states that the positive closed-fracture result cannot be extended. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Materials separating populations and estimated results of the two prespecified cohorts	Present population-specific estimates and applicability side by side
3	Partly verified	Full text not readStored summary read	N03 · Efficacy comparison · Preserved-material preparationWhat is the actual denominator for the open-fracture analysis?Required	The preserved summary gives 1,700 open-fracture patients. The evidence table’s 6,785 and 3,360/3,425 belong to closed fractures. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Open-fracture denominators for recruitment, assignment and analysis populations	Present clusters, people and group-specific analysis denominators separately
4	Unverified	Full text not readStored summary read	N04 · Efficacy comparison · Preserved-material preparationAre open-fracture severity and anatomical scope verified?Required	The summary identifies only the open-fracture population. The parent closed lower-extremity/pelvic-fracture label is not reused as an exact open-fracture location or severity criterion. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Open-fracture locations, injury severity, eligibility and exclusion criteria	Present the actual selected population and scope separately in the original report
5	Partly verified	Full text not readStored summary read	N05 · Efficacy comparison · Preserved-material preparationWhat are the two alcohol preparations compared in the trial?Required	Recorded preparations are 0.7% free iodine povacrylex with 74% isopropyl alcohol, and 2% chlorhexidine gluconate with 70% isopropyl alcohol. These identify research formulations and are not usage instructions. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Original identities of iodine-alcohol and chlorhexidine-alcohol formulations	Preserve formulation identities and applicability limits
6	Partly verified	Full text not readStored summary read	N06 · Efficacy comparison · Preserved-material preparationCan this be extended to other antiseptics or surgeries?Required	The parent summary specifies a comparison of two particular alcohol preparations and states that it cannot be extended to open fractures, other surgeries or aqueous iodine. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Direct evidence matching the actual formulations and surgical context	Express formulation- and surgery-specific results as separate questions
7	Unverified	Full text not readStored summary read	N07 · Efficacy comparison · Preserved-material preparationAre concurrent antibiotics, irrigation and fixation exposures accounted for in the group comparison?Required	The preserved material describes skin-antiseptic comparisons but no open-fracture-specific antibiotic, irrigation, fixation or other concurrent-exposure details. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Actual surgery, antibiotics, injury care and deviation information by group	Present concurrent exposures and deviations by group
8	Partly verified	Full text not readStored summary read	N08 · Efficacy comparison · Preserved-material preparationWhat are the randomization unit and alternating-use structure?Required	This was a cluster-randomized crossover trial in which 25 US/Canadian hospitals alternated the two preparations every two months. Assignment was at cluster-period level and is not relabeled as individual assignment. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Design materials distinguishing hospitals, cluster-periods and individuals	Present assignment units separately from participant units
9	Partly verified	Full text not readStored summary read	N09 · Efficacy comparison · Preserved-material preparationWhat is the scope of current evidence on allocation sequence and concealment?Required	The preserved summary quotes a Methods Centre computer-generated sequence and cluster-period allocation implementation. Parent B0 is historical verdict information; the original paper’s methods were not reviewed here. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Allocation wording in the preserved summary actually read and original methods materials	Present cluster-allocation implementation separately from recruitment timing
10	Unverified	Full text not readStored summary read	N10 · Efficacy comparison · Preserved-material preparationWere crossover periods and temporal effects reflected in open-fracture effect estimation?Required	The summary describes two-month alternation but no detailed period/cluster effects or crossover handling in the open-fracture model. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Specifications of period effects, cluster correlation, crossover and analysis model	Present period and cluster handling from the original model
11	Partly verified	Full text not readStored summary read	N11 · Efficacy comparison · Preserved-material preparationWhat are the SSI definition and ascertainment times?Required	The trial’s primary endpoint is summarized as superficial incisional infection within 30 days or deep/organ-space infection within 90 days. Symptom scores or all infections are not labeled as this same endpoint. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Adjudication criteria and periods for superficial, deep and organ-space infection	Present results by definition, time and infection type
12	Partly verified	Full text not readStored summary read	N12 · Efficacy comparison · Preserved-material preparationAre infection-adjudication masking and surgical-team masking distinguished?Required	The preserved summary records central adjudication unaware of assignment and infeasible surgical-team masking due to preparation characteristics. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Masking scope for outcome adjudicators and actual surgical teams	Distinguish masking of outcome adjudication from intervention implementation
13	Partly verified	Full text not readStored summary read	N13 · Efficacy comparison · Preserved-material preparationCan the follow-up completion rate be used as an open-fracture denominator?Required	The preserved summary gives 95% primary-analysis follow-up. It does not explicitly state that this sentence applies exclusively to open fractures. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Open-fracture group-specific follow-up completion, missingness and withdrawal reasons	Present actual open-fracture follow-up and missingness denominators separately
14	Partly verified	Full text not readStored summary read	N14 · Efficacy comparison · Preserved-material preparationWhat are the analysis population of interest and assignment basis?Required	The preserved analysis sentence describes eligible enrolled patients analyzed according to the antiseptic assigned to their hospital during that crossover period. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Assignment-based analysis principles and actual inclusion/exclusion materials	Distinguish assignment effects from effects of preparations actually received
15	Partly verified	Full text not readStored summary read	N15 · Efficacy comparison · Preserved-material preparationAre infection event counts and group denominators provided for open fractures?Required	Open-fracture results are summarized as 6.5% versus 7.3%. That summary gives no group event counts or denominators. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Original result tables including each group’s events, denominators and analysis units	Present actual open-fracture events together with analysis denominators
16	Partly verified	Full text not readStored summary read	N16 · Efficacy comparison · Preserved-material preparationHow are the open-fracture comparison effect and confidence interval recorded?Required	The open-fracture summary records a null result: OR 0.86, 95% CI 0.58–1.27, P=0.45. The original effect and scope are preserved. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Effect measure, interval and P value for the selected population	Present the original effect, interval, test and interpretation scope separately
17	Unverified	Full text not readStored summary read	N17 · Efficacy comparison · Preserved-material preparationAre an open-fracture absolute risk difference and interval available?Required	The preserved summary has open-fracture proportions and OR, but no open-fracture absolute risk difference or its interval. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Directly reported absolute effect and uncertainty for the selected population	If an absolute effect is reported, present the selected population’s value and interval
18	Unverified	Full text not readStored summary read	N18 · Efficacy comparison · Preserved-material preparationAre open-fracture OR adjustment terms and target effect verified?Required	The closed-fracture summary explicitly says adjusted OR; the existing open-fracture counterview records OR 0.86. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Open-fracture adjustment model, covariates, cluster handling and effect of interest	Present population-specific estimates’ meaning from the original report
19	Partly verified	Full text not readStored summary read	N19 · Efficacy comparison · Preserved-material preparationWere the open-fracture population and registration timing distinguished prospectively?Required	The summary records closed/open fractures as separate prespecified populations and registration in 2018 before recruitment. The registration number is NCT03523962. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Original population distinction, registration contents and dates	Present connections between population-specific plans and reported results
20	Unverified	Full text not readStored summary read	N20 · Efficacy comparison · Preserved-material preparationAre analysis plans, multiplicity and infection-subtype hierarchy verified?Required	The preserved summary describes the primary infection endpoint and advance population distinction. It gives no detailed within-open-fracture analysis hierarchy or multiplicity handling. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Protocol, SAP, subtype and population-specific testing plans	Connect the selected population’s prespecified analysis hierarchy with result tables
21	Partly verified	Full text not readStored summary read	N21 · Efficacy comparison · Preserved-material preparationDo different closed/open-fracture results prove interaction?Required	Closed-fracture results are borderline at P=0.049 and OR CI upper limit 0.999; open-fracture P=0.45. The preserved review summary distinguishes the populations. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Population-specific effects and formal interaction or direct-comparison analyses	Distinguish different-population results from direct tests of differences
22	Partly verified	Full text not readStored summary read	N22 · Efficacy comparison · Preserved-material preparationWere the report, registration and related sheets counted as independent repeat trials?Required	The original bibliography is one PREP-IT 2024 paper linked to NCT03523962. Related closed-fracture and selected open-fracture sheets share the parent summary. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Population, bibliography and registration connections in the same PREPARE report	Preserve report slots separately from trial and participant units
23	Partly verified	Full text not readStored summary read	N23 · Efficacy comparison · Preserved-material preparationWhat evidence supports contrary results in other surgeries?Required	The existing counterview mentions results favoring chlorhexidine in clean/contaminated surgeries and cesarean sections. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Actual bibliography and populations for clean/contaminated-surgery and cesarean reports	Present other-surgery results only as context for their own populations
24	Partly verified	Full text not readStored summary read	N24 · Efficacy comparison · Preserved-material preparationAre long-term results and infection-type follow-up verified for the selected population?Required	The preserved summary defines infection adjudication at 30/90 days and separately describes one-year reoperation in safety information. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Open-fracture infection results by time and long-term clinical outcomes	Present infection-adjudication times separately from long-term clinical follow-up
25	Partly verified	Full text not readStored summary read	N25 · Efficacy comparison · Preserved-material preparationIs the material currently read the full original open-fracture paper?Required	The preserved summary was actually read. The citation list contains the paper bibliography, but the evidence list’s title, population size and results are PREPARE Closed. Selected open-fracture results appear in the existing counterview. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Access distinctions among summary copy, external abstract/full text, registration and plans	Mark summary reading separately from unread external materials
26	Partly verified	Full text not readStored summary read	N26 · Efficacy comparison · Preserved-material preparationAre public funding and manufacturer-involvement items distinguished?Required	PCORI and CIHR supported the trial, operated by McMaster University and the University of Maryland Baltimore. The summary states that manufacturer product donations, commercial analysis, medical writing and publication funding were not reported. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Original research-funding, product-support, outsourced-analysis, medical-writing and publication-cost disclosures	Distinguish reported support from unknown involvement
27	Unverified	Full text not readStored summary read	N27 · Efficacy comparison · Preserved-material preparationAre author affiliations, company roles and data control verified?Required	The preserved summary describes public funding, operating institutions and nonreporting of some manufacturer support. It has no complete author-specific company-relationship or data-control items. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Employee-author, advisory, data-access, design, analysis and publication-role disclosures	Present public funding separately from author-specific independence
28	Partly verified	Full text not readStored summary read	N28 · Supplementary harm evidenceCan one-year reoperation be used as open-fracture harms or efficacy evidence?Supplementary	The safety summary describes similar unplanned one-year reoperation: 5.5% versus 5.9%, OR 0.96, 95% CI 0.77–1.20. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Actual population, group-specific denominators and definition for that outcome	Present reoperation, infection and populations separately
29	Partly verified	Full text not readStored summary read	N29 · Supplementary harm evidenceWhat is the scope of unreported chemical burns and intraoperative fires?Supplementary	The original safety sentence states that no alcohol-preparation-related chemical burns or intraoperative fires were reported in the overall trial. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Harms collection, event definitions, exposure and population denominators	Present harms-reporting scope together with actual observation denominators
30	Unverified	Full text not readStored summary read	N30 · Supplementary harm evidenceAre long-term/rare harms and other wound-related events verified?Supplementary	The preserved safety summary contains some reoperation and chemical-burn/fire information, but no complete open-fracture rare-harms or long-term-outcome table. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Long-term exposure, follow-up and rare-event materials for the selected population	Present long-term harms gaps separately from efficacy
31	Partly verified	Full text not readStored summary read	N31 · Efficacy comparison · Preserved-material preparationAre Korean/English prose, axes, reference date and correction history preserved in original form?Required	Parent Korean/English prose, axes, the 2026-08-26 reference date, empty corrections array and deliberation string, and selected subclaim are preserved in the complete existing summary. The reference date is not the current review date. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Copies of parent Korean/English prose, axes, reference date, corrections and original subclaim	Separate existing verdict, dates and corrections from this preparation event
32	Partly verified	Full text not readStored summary read	N32 · Efficacy comparison · Preserved-material preparationAre historical candidate metadata and current preparation status separated?Required	Only the existing subclaim unit is prepared, with parent and selected-row connections distinguished. Candidate review-pending, production-eligibility and independence markers remain historical original-selection metadata. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Distinction between existing selection and preparation, review and independence status	Connect original-record changes separately from preparation and existing content-review events

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32 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-08-26
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: This is the date the stored materials were checked, not the date of a new search of the clinical literature.
Population: PREPARE’s separate prespecified open-fracture population of 1,700 patients; detailed locations, severity and eligibility criteria unverified
Ingredient, formulation and route: Trial iodine povacrylex-alcohol preparation
Dose: Research formulation: 0.7% free iodine and 74% isopropyl alcohol; not implementation guidance
Comparator: Research formulation: 2% chlorhexidine gluconate and 70% isopropyl alcohol
Measured outcome: Surgical-site infection; distinguish the trial’s superficial 30-day and deep/organ-space 90-day definitions from open-fracture-specific material gaps
Duration: Infection adjudication at 30 or 90 days; one-year reoperation is a separate outcome with open-fracture-specific scope unverified
Questions outside this scope: No new formulations, populations, clinical effects, CI, verdicts, independence certification, participant totals, implementation or treatment instructions are created

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

R01 · PREP-IT Investigators. Skin Antisepsis before Surgical Fixation of Extremity Fractures. N Engl J Med. 2024;390:409-420. PMID: 38294973.

PubMed

Material type: Preserved summary of trial-paper bibliography
Materials actually read: Stored summary read; external abstracts, full texts, registrations and plans unread
Findings recorded in the stored summary: The separate prespecified open-fracture population of 1,700 patients had a null result: 6.5% versus 7.3%, OR 0.86 (95% CI 0.58–1.27), P=0.45. Closed-fracture results cannot be extended to open fractures, other surgeries or aqueous iodine; clean/contaminated-surgery and cesarean trials also included results favoring chlorhexidine.
Record level: OR, CI and P in the existing open-fracture counterview; the first evidence record’s closed-fracture population size and effect are not reused
Study overlap and independent replication: Preserve connections among selected open fractures, parent closed fractures, the same paper and registration; different populations are not certified as independent replication

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Summary read	Stored summary read	Summary read	Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented
External abstract	Not read	External material unread	Not read	Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented
External full text	Not read	External material unread	Not read	Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented
Original registration	Not read	External material unread	Not read	Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented
Protocol/SAP	Not read	External material unread	Not read	Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented

Report counts versus independent study counts

Preserve connections among selected open fractures, parent closed fractures, the same paper and registration; different populations are not certified as independent replication

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · Is the selected subclaim reduced infection after open-fracture fixation?

Required materials and conditions: Distinction between original selected question, subclaim grade/note and parent verdict
Conditions for verification: Distinction between original selected question, subclaim grade/note and parent verdict; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N02 · Can the positive closed-fracture result be applied to open fractures?

Required materials and conditions: Materials separating populations and estimated results of the two prespecified cohorts
Conditions for verification: Materials separating populations and estimated results of the two prespecified cohorts; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N03 · What is the actual denominator for the open-fracture analysis?

Required materials and conditions: Open-fracture denominators for recruitment, assignment and analysis populations
Conditions for verification: Open-fracture denominators for recruitment, assignment and analysis populations; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N04 · Are open-fracture severity and anatomical scope verified?

Required materials and conditions: Open-fracture locations, injury severity, eligibility and exclusion criteria
Conditions for verification: Open-fracture locations, injury severity, eligibility and exclusion criteria; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N05 · What are the two alcohol preparations compared in the trial?

Required materials and conditions: Original identities of iodine-alcohol and chlorhexidine-alcohol formulations
Conditions for verification: Original identities of iodine-alcohol and chlorhexidine-alcohol formulations; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N06 · Can this be extended to other antiseptics or surgeries?

Required materials and conditions: Direct evidence matching the actual formulations and surgical context
Conditions for verification: Direct evidence matching the actual formulations and surgical context; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N07 · Are concurrent antibiotics, irrigation and fixation exposures accounted for in the group comparison?

Required materials and conditions: Actual surgery, antibiotics, injury care and deviation information by group
Conditions for verification: Actual surgery, antibiotics, injury care and deviation information by group; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N08 · What are the randomization unit and alternating-use structure?

Required materials and conditions: Design materials distinguishing hospitals, cluster-periods and individuals
Conditions for verification: Design materials distinguishing hospitals, cluster-periods and individuals; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N09 · What is the scope of current evidence on allocation sequence and concealment?

Required materials and conditions: Allocation wording in the preserved summary actually read and original methods materials
Conditions for verification: Allocation wording in the preserved summary actually read and original methods materials; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N10 · Were crossover periods and temporal effects reflected in open-fracture effect estimation?

Required materials and conditions: Specifications of period effects, cluster correlation, crossover and analysis model
Conditions for verification: Specifications of period effects, cluster correlation, crossover and analysis model; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N11 · What are the SSI definition and ascertainment times?

Required materials and conditions: Adjudication criteria and periods for superficial, deep and organ-space infection
Conditions for verification: Adjudication criteria and periods for superficial, deep and organ-space infection; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N12 · Are infection-adjudication masking and surgical-team masking distinguished?

Required materials and conditions: Masking scope for outcome adjudicators and actual surgical teams
Conditions for verification: Masking scope for outcome adjudicators and actual surgical teams; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N13 · Can the follow-up completion rate be used as an open-fracture denominator?

Required materials and conditions: Open-fracture group-specific follow-up completion, missingness and withdrawal reasons
Conditions for verification: Open-fracture group-specific follow-up completion, missingness and withdrawal reasons; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N14 · What are the analysis population of interest and assignment basis?

Required materials and conditions: Assignment-based analysis principles and actual inclusion/exclusion materials
Conditions for verification: Assignment-based analysis principles and actual inclusion/exclusion materials; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N15 · Are infection event counts and group denominators provided for open fractures?

Required materials and conditions: Original result tables including each group’s events, denominators and analysis units
Conditions for verification: Original result tables including each group’s events, denominators and analysis units; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N16 · How are the open-fracture comparison effect and confidence interval recorded?

Required materials and conditions: Effect measure, interval and P value for the selected population
Conditions for verification: Effect measure, interval and P value for the selected population; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N17 · Are an open-fracture absolute risk difference and interval available?

Required materials and conditions: Directly reported absolute effect and uncertainty for the selected population
Conditions for verification: Directly reported absolute effect and uncertainty for the selected population; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N18 · Are open-fracture OR adjustment terms and target effect verified?

Required materials and conditions: Open-fracture adjustment model, covariates, cluster handling and effect of interest
Conditions for verification: Open-fracture adjustment model, covariates, cluster handling and effect of interest; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N19 · Were the open-fracture population and registration timing distinguished prospectively?

Required materials and conditions: Original population distinction, registration contents and dates
Conditions for verification: Original population distinction, registration contents and dates; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N20 · Are analysis plans, multiplicity and infection-subtype hierarchy verified?

Required materials and conditions: Protocol, SAP, subtype and population-specific testing plans
Conditions for verification: Protocol, SAP, subtype and population-specific testing plans; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N21 · Do different closed/open-fracture results prove interaction?

Required materials and conditions: Population-specific effects and formal interaction or direct-comparison analyses
Conditions for verification: Population-specific effects and formal interaction or direct-comparison analyses; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N22 · Were the report, registration and related sheets counted as independent repeat trials?

Required materials and conditions: Population, bibliography and registration connections in the same PREPARE report
Conditions for verification: Population, bibliography and registration connections in the same PREPARE report; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N23 · What evidence supports contrary results in other surgeries?

Required materials and conditions: Actual bibliography and populations for clean/contaminated-surgery and cesarean reports
Conditions for verification: Actual bibliography and populations for clean/contaminated-surgery and cesarean reports; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N24 · Are long-term results and infection-type follow-up verified for the selected population?

Required materials and conditions: Open-fracture infection results by time and long-term clinical outcomes
Conditions for verification: Open-fracture infection results by time and long-term clinical outcomes; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N25 · Is the material currently read the full original open-fracture paper?

Required materials and conditions: Access distinctions among summary copy, external abstract/full text, registration and plans
Conditions for verification: Access distinctions among summary copy, external abstract/full text, registration and plans; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N26 · Are public funding and manufacturer-involvement items distinguished?

Required materials and conditions: Original research-funding, product-support, outsourced-analysis, medical-writing and publication-cost disclosures
Conditions for verification: Original research-funding, product-support, outsourced-analysis, medical-writing and publication-cost disclosures; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N27 · Are author affiliations, company roles and data control verified?

Required materials and conditions: Employee-author, advisory, data-access, design, analysis and publication-role disclosures
Conditions for verification: Employee-author, advisory, data-access, design, analysis and publication-role disclosures; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N28 · Can one-year reoperation be used as open-fracture harms or efficacy evidence?

Required materials and conditions: Actual population, group-specific denominators and definition for that outcome
Conditions for verification: Actual population, group-specific denominators and definition for that outcome; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Requirement and applicability: Supplementary
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Supplementary condition showing limits of harms/safety information separately from efficacy
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N29 · What is the scope of unreported chemical burns and intraoperative fires?

Required materials and conditions: Harms collection, event definitions, exposure and population denominators
Conditions for verification: Harms collection, event definitions, exposure and population denominators; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Requirement and applicability: Supplementary
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Supplementary condition showing limits of harms/safety information separately from efficacy
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N30 · Are long-term/rare harms and other wound-related events verified?

Required materials and conditions: Long-term exposure, follow-up and rare-event materials for the selected population
Conditions for verification: Long-term exposure, follow-up and rare-event materials for the selected population; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Requirement and applicability: Supplementary
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Supplementary condition showing limits of harms/safety information separately from efficacy
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N31 · Are Korean/English prose, axes, reference date and correction history preserved in original form?

Required materials and conditions: Copies of parent Korean/English prose, axes, reference date, corrections and original subclaim
Conditions for verification: Copies of parent Korean/English prose, axes, reference date, corrections and original subclaim; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N32 · Are historical candidate metadata and current preparation status separated?

Required materials and conditions: Distinction between existing selection and preparation, review and independence status
Conditions for verification: Distinction between existing selection and preparation, review and independence status; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle: Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle: Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

What the statuses mean

Partly verified: Some information exists in the preserved review summary; detailed original materials remain unverified. This does not certify a passed review or clinical efficacy.
Unverified: Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety
Review incomplete: Review of existing content incomplete
Met: Use only within the relevant conditions after existing content review; no automatic designation in this preparation
Not reported: Distinguish only within materials actually read; do not turn unread external materials into unreported findings
Inaccessible: Not applied during this preparation because actual access was not tested
Not applicable: Use with a reason for non-applicability based on an explicit question boundary
Conflicting data: Judge after actual material comparison; review was not performed during this preparation
Insufficient evidence for the conditions: Do not use as a clinical grade encompassing currently unread materials

Change history

2026-10-13 · Public page/material version 1.0

Public pages and materials were prepared from the existing 32 items. No new clinical search, verification-status change or scoring was performed.

The stored-material review date (Not recorded) and original evidence cut-off (2026-08-26) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · Is the selected subclaim reduced infection after open-fracture fixation?

Current findings: The preserved subclaim is reduced SSI after open-fracture fixation, originally graded D, with a note that the separate population was null at P=0.45. Parent B with 76 points and axes concern closed fractures. The selected row has no score, status or axes in the summary.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Do not fill subclaim score, status or axes with parent values. No new verdict or boundary certification was written.
Required materials and conditions: Distinction between original selected question, subclaim grade/note and parent verdict
Materials to obtain first: Original selected subclaim and parent verdict
Further research: Present the original records so the user can read the subclaim separately from parent context
Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed
Conditions for verification: Distinction between original selected question, subclaim grade/note and parent verdict; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N02 · Can the positive closed-fracture result be applied to open fractures?

Current findings: The preserved summary distinguishes closed and open fractures as separate prespecified populations. It records a null open-fracture result and states that the positive closed-fracture result cannot be extended.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Closed-fracture B with 76 points and -0.8 percentage points cannot be transferred as an open-fracture effect or score.
Required materials and conditions: Materials separating populations and estimated results of the two prespecified cohorts
Materials to obtain first: Original result tables and registration plan for both populations
Further research: Present population-specific estimates and applicability side by side
Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed
Conditions for verification: Materials separating populations and estimated results of the two prespecified cohorts; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N03 · What is the actual denominator for the open-fracture analysis?

Current findings: The preserved summary gives 1,700 open-fracture patients. The evidence table’s 6,785 and 3,360/3,425 belong to closed fractures.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Group-specific open-fracture allocation, analysis and follow-up denominators are absent from the summary. Do not sum the two populations as a participant total.
Required materials and conditions: Open-fracture denominators for recruitment, assignment and analysis populations
Materials to obtain first: Open-fracture CONSORT flow and group-specific analysis tables
Further research: Present clusters, people and group-specific analysis denominators separately
Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed
Conditions for verification: Open-fracture denominators for recruitment, assignment and analysis populations; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N04 · Are open-fracture severity and anatomical scope verified?

Current findings: The summary identifies only the open-fracture population. The parent closed lower-extremity/pelvic-fracture label is not reused as an exact open-fracture location or severity criterion.
Verification status: Unverified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Open-fracture classification, contamination, injury location and detailed patient characteristics are unverified within the preserved scope.
Required materials and conditions: Open-fracture locations, injury severity, eligibility and exclusion criteria
Materials to obtain first: Open-fracture eligibility, baseline characteristics and prespecified subgroup tables
Further research: Present the actual selected population and scope separately in the original report
Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed
Conditions for verification: Open-fracture locations, injury severity, eligibility and exclusion criteria; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N05 · What are the two alcohol preparations compared in the trial?

Current findings: Recorded preparations are 0.7% free iodine povacrylex with 74% isopropyl alcohol, and 2% chlorhexidine gluconate with 70% isopropyl alcohol. These identify research formulations and are not usage instructions.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Product, batch, application-process and shared-care details remain unread; equivalence of aqueous iodine or other concentrations is not established.
Required materials and conditions: Original identities of iodine-alcohol and chlorhexidine-alcohol formulations
Materials to obtain first: Trial-preparation specifications and original intervention descriptions
Further research: Preserve formulation identities and applicability limits
Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed
Conditions for verification: Original identities of iodine-alcohol and chlorhexidine-alcohol formulations; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N06 · Can this be extended to other antiseptics or surgeries?

Current findings: The parent summary specifies a comparison of two particular alcohol preparations and states that it cannot be extended to open fractures, other surgeries or aqueous iodine.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: The selected question’s null result does not prove equivalence of every iodine or chlorhexidine preparation.
Required materials and conditions: Direct evidence matching the actual formulations and surgical context
Materials to obtain first: Direct comparison of the same open-fracture population and formulations
Further research: Express formulation- and surgery-specific results as separate questions
Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed
Conditions for verification: Direct evidence matching the actual formulations and surgical context; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N07 · Are concurrent antibiotics, irrigation and fixation exposures accounted for in the group comparison?

Current findings: The preserved material describes skin-antiseptic comparisons but no open-fracture-specific antibiotic, irrigation, fixation or other concurrent-exposure details.
Verification status: Unverified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Balance, changes and separation of concurrent-treatment effects remain unverified. No implementation or treatment-change instructions are written.
Required materials and conditions: Actual surgery, antibiotics, injury care and deviation information by group
Materials to obtain first: Open-fracture shared-care and concurrent-exposure tables
Further research: Present concurrent exposures and deviations by group
Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed
Conditions for verification: Actual surgery, antibiotics, injury care and deviation information by group; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N08 · What are the randomization unit and alternating-use structure?

Current findings: This was a cluster-randomized crossover trial in which 25 US/Canadian hospitals alternated the two preparations every two months. Assignment was at cluster-period level and is not relabeled as individual assignment.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Cluster counts, cluster-periods and patients are different units. Open-fracture recruitment distribution by period is absent from the summary.
Required materials and conditions: Design materials distinguishing hospitals, cluster-periods and individuals
Materials to obtain first: Cluster-period allocation tables and recruitment distribution
Further research: Present assignment units separately from participant units
Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed
Conditions for verification: Design materials distinguishing hospitals, cluster-periods and individuals; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N09 · What is the scope of current evidence on allocation sequence and concealment?

Current findings: The preserved summary quotes a Methods Centre computer-generated sequence and cluster-period allocation implementation. Parent B0 is historical verdict information; the original paper’s methods were not reviewed here.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Actual concealment processes, advance accessibility and open-fracture recruitment implications remain externally unread.
Required materials and conditions: Allocation wording in the preserved summary actually read and original methods materials
Materials to obtain first: Original paper allocation methods and operating records
Further research: Present cluster-allocation implementation separately from recruitment timing
Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed
Conditions for verification: Allocation wording in the preserved summary actually read and original methods materials; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N10 · Were crossover periods and temporal effects reflected in open-fracture effect estimation?

Current findings: The summary describes two-month alternation but no detailed period/cluster effects or crossover handling in the open-fracture model.
Verification status: Unverified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: No new inference is made about analysis of temporal changes, cluster-period correlation or carryover.
Required materials and conditions: Specifications of period effects, cluster correlation, crossover and analysis model
Materials to obtain first: Open-fracture analysis model and prespecified statistical plan
Further research: Present period and cluster handling from the original model
Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed
Conditions for verification: Specifications of period effects, cluster correlation, crossover and analysis model; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N11 · What are the SSI definition and ascertainment times?

Current findings: The trial’s primary endpoint is summarized as superficial incisional infection within 30 days or deep/organ-space infection within 90 days. Symptom scores or all infections are not labeled as this same endpoint.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Open-fracture infection subtypes, specific diagnostic documents and event-level ascertainment remain unread in the original report.
Required materials and conditions: Adjudication criteria and periods for superficial, deep and organ-space infection
Materials to obtain first: Infection-adjudication manual and open-fracture subtype event tables
Further research: Present results by definition, time and infection type
Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed
Conditions for verification: Adjudication criteria and periods for superficial, deep and organ-space infection; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N12 · Are infection-adjudication masking and surgical-team masking distinguished?

Current findings: The preserved summary records central adjudication unaware of assignment and infeasible surgical-team masking due to preparation characteristics.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Missing open-fracture adjudication materials, agreement and reassessment processes remain unread. Perfect masking of everything is not certified.
Required materials and conditions: Masking scope for outcome adjudicators and actual surgical teams
Materials to obtain first: Central-adjudication procedures and material flow
Further research: Distinguish masking of outcome adjudication from intervention implementation
Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed
Conditions for verification: Masking scope for outcome adjudicators and actual surgical teams; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N13 · Can the follow-up completion rate be used as an open-fracture denominator?

Current findings: The preserved summary gives 95% primary-analysis follow-up. It does not explicitly state that this sentence applies exclusively to open fractures.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Do not calculate open-fracture follow-up numbers from 95% or establish it as the completion rate of every group.
Required materials and conditions: Open-fracture group-specific follow-up completion, missingness and withdrawal reasons
Materials to obtain first: Population-specific follow-up flow and missing-data handling tables
Further research: Present actual open-fracture follow-up and missingness denominators separately
Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed
Conditions for verification: Open-fracture group-specific follow-up completion, missingness and withdrawal reasons; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N14 · What are the analysis population of interest and assignment basis?

Current findings: The preserved analysis sentence describes eligible enrolled patients analyzed according to the antiseptic assigned to their hospital during that crossover period.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Actual open-fracture analysis numbers, allocation deviations, preparation changes and inclusion/exclusion reasons are unverified in original materials.
Required materials and conditions: Assignment-based analysis principles and actual inclusion/exclusion materials
Materials to obtain first: Open-fracture analysis-population specifications and deviation tables
Further research: Distinguish assignment effects from effects of preparations actually received
Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed
Conditions for verification: Assignment-based analysis principles and actual inclusion/exclusion materials; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N15 · Are infection event counts and group denominators provided for open fractures?

Current findings: Open-fracture results are summarized as 6.5% versus 7.3%. That summary gives no group event counts or denominators.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Do not copy closed-fracture 77/3,360 or 108/3,425 or calculate open-fracture event counts from proportions.
Required materials and conditions: Original result tables including each group’s events, denominators and analysis units
Materials to obtain first: Original open-fracture infection-event and denominator tables
Further research: Present actual open-fracture events together with analysis denominators
Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed
Conditions for verification: Original result tables including each group’s events, denominators and analysis units; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N16 · How are the open-fracture comparison effect and confidence interval recorded?

Current findings: The open-fracture summary records a null result: OR 0.86, 95% CI 0.58–1.27, P=0.45. The original effect and scope are preserved.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Do not turn a null result with a wide interval into exactly zero effect or proof that the two preparations are equivalent.
Required materials and conditions: Effect measure, interval and P value for the selected population
Materials to obtain first: Original open-fracture OR results and model explanation
Further research: Present the original effect, interval, test and interpretation scope separately
Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed
Conditions for verification: Effect measure, interval and P value for the selected population; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N17 · Are an open-fracture absolute risk difference and interval available?

Current findings: The preserved summary has open-fracture proportions and OR, but no open-fracture absolute risk difference or its interval.
Verification status: Unverified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Do not reuse closed-fracture adjusted -0.8 percentage points and its interval or calculate a new absolute difference/NNT from 6.5% and 7.3%.
Required materials and conditions: Directly reported absolute effect and uncertainty for the selected population
Materials to obtain first: Directly reported open-fracture absolute-effect table
Further research: If an absolute effect is reported, present the selected population’s value and interval
Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed
Conditions for verification: Directly reported absolute effect and uncertainty for the selected population; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N18 · Are open-fracture OR adjustment terms and target effect verified?

Current findings: The closed-fracture summary explicitly says adjusted OR; the existing open-fracture counterview records OR 0.86.
Verification status: Unverified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Do not automatically apply closed-fracture adjustment specifications to open fractures or create adjusted effects absent from the original.
Required materials and conditions: Open-fracture adjustment model, covariates, cluster handling and effect of interest
Materials to obtain first: Open-fracture model, estimand and covariate specifications
Further research: Present population-specific estimates’ meaning from the original report
Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed
Conditions for verification: Open-fracture adjustment model, covariates, cluster handling and effect of interest; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

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N19 · Were the open-fracture population and registration timing distinguished prospectively?

Current findings: The summary records closed/open fractures as separate prespecified populations and registration in 2018 before recruitment. The registration number is NCT03523962.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Original registration, revision history and detailed open-fracture plans were not read here.
Required materials and conditions: Original population distinction, registration contents and dates
Materials to obtain first: Original NCT03523962 registration and revision history
Further research: Present connections between population-specific plans and reported results
Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed
Conditions for verification: Original population distinction, registration contents and dates; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N20 · Are analysis plans, multiplicity and infection-subtype hierarchy verified?

Current findings: The preserved summary describes the primary infection endpoint and advance population distinction. It gives no detailed within-open-fracture analysis hierarchy or multiplicity handling.
Verification status: Unverified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Do not establish planning-document existence, contents, agreement or all additional open-fracture analyses.
Required materials and conditions: Protocol, SAP, subtype and population-specific testing plans
Materials to obtain first: Protocol, SAP and endpoint-hierarchy documents
Further research: Connect the selected population’s prespecified analysis hierarchy with result tables
Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed
Conditions for verification: Protocol, SAP, subtype and population-specific testing plans; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N21 · Do different closed/open-fracture results prove interaction?

Current findings: Closed-fracture results are borderline at P=0.049 and OR CI upper limit 0.999; open-fracture P=0.45. The preserved review summary distinguishes the populations.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Significance in one population and a null result in another do not newly establish interaction or superiority between populations.
Required materials and conditions: Population-specific effects and formal interaction or direct-comparison analyses
Materials to obtain first: Original prespecified population effects and interaction analyses
Further research: Distinguish different-population results from direct tests of differences
Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed
Conditions for verification: Population-specific effects and formal interaction or direct-comparison analyses; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N22 · Were the report, registration and related sheets counted as independent repeat trials?

Current findings: The original bibliography is one PREP-IT 2024 paper linked to NCT03523962. Related closed-fracture and selected open-fracture sheets share the parent summary.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Do not sum the paper, registration, two populations or related sheets as new independent trials or participant totals. Confirmed independent-trial count remains unrecorded.
Required materials and conditions: Population, bibliography and registration connections in the same PREPARE report
Materials to obtain first: Connections among the same report, registration and populations
Further research: Preserve report slots separately from trial and participant units
Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed
Conditions for verification: Population, bibliography and registration connections in the same PREPARE report; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N23 · What evidence supports contrary results in other surgeries?

Current findings: The existing counterview mentions results favoring chlorhexidine in clean/contaminated surgeries and cesarean sections.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Exact bibliographies, trial counts, denominators and effects for those reports are absent from the summary. Do not invent papers or elevate them to open-fracture replication evidence.
Required materials and conditions: Actual bibliography and populations for clean/contaminated-surgery and cesarean reports
Materials to obtain first: Identifying materials for other-surgery reports mentioned as context
Further research: Present other-surgery results only as context for their own populations
Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed
Conditions for verification: Actual bibliography and populations for clean/contaminated-surgery and cesarean reports; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N24 · Are long-term results and infection-type follow-up verified for the selected population?

Current findings: The preserved summary defines infection adjudication at 30/90 days and separately describes one-year reoperation in safety information.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Do not fill open-fracture-specific long-term infection, recovery, reoperation effects or other clinical outcomes with short-term infection rates.
Required materials and conditions: Open-fracture infection results by time and long-term clinical outcomes
Materials to obtain first: Open-fracture infection results by time and long-term outcome tables
Further research: Present infection-adjudication times separately from long-term clinical follow-up
Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed
Conditions for verification: Open-fracture infection results by time and long-term clinical outcomes; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N25 · Is the material currently read the full original open-fracture paper?

Current findings: The preserved summary was actually read. The citation list contains the paper bibliography, but the evidence list’s title, population size and results are PREPARE Closed. Selected open-fracture results appear in the existing counterview.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: External abstract, full text, registration, protocol and SAP remain unread. URL existence does not establish reading or content certification.
Required materials and conditions: Access distinctions among summary copy, external abstract/full text, registration and plans
Materials to obtain first: Original report, abstract/full text, registration and plans for the selected population
Further research: Mark summary reading separately from unread external materials
Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed
Conditions for verification: Access distinctions among summary copy, external abstract/full text, registration and plans; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

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N26 · Are public funding and manufacturer-involvement items distinguished?

Current findings: PCORI and CIHR supported the trial, operated by McMaster University and the University of Maryland Baltimore. The summary states that manufacturer product donations, commercial analysis, medical writing and publication funding were not reported.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Scope of unreported disclosures differs from certification of no involvement. Separate open-fracture support, contracts and full COI remain externally unread.
Required materials and conditions: Original research-funding, product-support, outsourced-analysis, medical-writing and publication-cost disclosures
Materials to obtain first: Funding, product, analysis, writing and publication disclosures and role specifications
Further research: Distinguish reported support from unknown involvement
Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed
Conditions for verification: Original research-funding, product-support, outsourced-analysis, medical-writing and publication-cost disclosures; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N27 · Are author affiliations, company roles and data control verified?

Current findings: The preserved summary describes public funding, operating institutions and nonreporting of some manufacturer support. It has no complete author-specific company-relationship or data-control items.
Verification status: Unverified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Do not newly certify no company employee authors or no commercial relationships of any kind.
Required materials and conditions: Employee-author, advisory, data-access, design, analysis and publication-role disclosures
Materials to obtain first: Author disclosures, contributions and data/publication-rights records
Further research: Present public funding separately from author-specific independence
Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed
Conditions for verification: Employee-author, advisory, data-access, design, analysis and publication-role disclosures; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N28 · Can one-year reoperation be used as open-fracture harms or efficacy evidence?

Current findings: The safety summary describes similar unplanned one-year reoperation: 5.5% versus 5.9%, OR 0.96, 95% CI 0.77–1.20.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: The preserved summary does not establish whether this sentence is open-fracture-specific, parent closed-fracture context or whole-trial scope. Do not combine it as the same endpoint as infection OR.
Required materials and conditions: Actual population, group-specific denominators and definition for that outcome
Materials to obtain first: Reoperation population, event-definition and group-denominator tables
Further research: Present reoperation, infection and populations separately
Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed
Conditions for verification: Actual population, group-specific denominators and definition for that outcome; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Why this condition is needed: Supplementary condition showing limits of harms/safety information separately from efficacy
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N29 · What is the scope of unreported chemical burns and intraoperative fires?

Current findings: The original safety sentence states that no alcohol-preparation-related chemical burns or intraoperative fires were reported in the overall trial.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Do not convert whole-trial nonreporting into zero open-fracture adverse events, no risk or complete collection.
Required materials and conditions: Harms collection, event definitions, exposure and population denominators
Materials to obtain first: Harms-collection methods and whole-trial/open-fracture event tables
Further research: Present harms-reporting scope together with actual observation denominators
Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed
Conditions for verification: Harms collection, event definitions, exposure and population denominators; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Why this condition is needed: Supplementary condition showing limits of harms/safety information separately from efficacy
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N30 · Are long-term/rare harms and other wound-related events verified?

Current findings: The preserved safety summary contains some reoperation and chemical-burn/fire information, but no complete open-fracture rare-harms or long-term-outcome table.
Verification status: Unverified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Selected-population long-term safety is not established; the historical parent Good safety label is preserved as historical context.
Required materials and conditions: Long-term exposure, follow-up and rare-event materials for the selected population
Materials to obtain first: Selected-population long-term follow-up and event/exposure denominators
Further research: Present long-term harms gaps separately from efficacy
Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed
Conditions for verification: Long-term exposure, follow-up and rare-event materials for the selected population; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Why this condition is needed: Supplementary condition showing limits of harms/safety information separately from efficacy
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N31 · Are Korean/English prose, axes, reference date and correction history preserved in original form?

Current findings: Parent Korean/English prose, axes, the 2026-08-26 reference date, empty corrections array and deliberation string, and selected subclaim are preserved in the complete existing summary. The reference date is not the current review date.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Retain absent subclaim score, status and axes; do not recalculate parent axes or grade as a new selected verdict.
Required materials and conditions: Copies of parent Korean/English prose, axes, reference date, corrections and original subclaim
Materials to obtain first: Preserved original review summary and change-event materials
Further research: Separate existing verdict, dates and corrections from this preparation event
Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed
Conditions for verification: Copies of parent Korean/English prose, axes, reference date, corrections and original subclaim; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

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N32 · Are historical candidate metadata and current preparation status separated?

Current findings: Only the existing subclaim unit is prepared, with parent and selected-row connections distinguished. Candidate review-pending, production-eligibility and independence markers remain historical original-selection metadata.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Content review belongs to the user; completed model/content/boundary review is not marked. Retain zero new structural units and unrecorded confirmed independent-trial/participant totals.
Required materials and conditions: Distinction between existing selection and preparation, review and independence status
Materials to obtain first: Existing selection original and condition/application preparation events
Further research: Connect original-record changes separately from preparation and existing content-review events
Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed
Conditions for verification: Distinction between existing selection and preparation, review and independence status; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01