{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2968-s1", "verdict_number": "2968", "title": "Iodine-alcohol preparation · Open-fracture surgical-site infection — Evidence Check", "view_version": "1.0", "view_created_date": "2026-10-13", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-08-26", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "The whole stored parent-verdict summary and selected subclaim were read for production. External papers, abstracts, full texts, registry, protocol, SAP and funding disclosures were not separately read or accessed. Historical review records are not inherited as current clinical verification or a new verdict.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "population": "PREPARE’s separate prespecified open-fracture population of 1,700 patients; detailed locations, severity and eligibility criteria unverified", "intervention": "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", "endpoint": "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", "excluded_extensions": [ "No new formulations, populations, clinical effects, CI, verdicts, independence certification, participant totals, implementation or treatment instructions are created" ] }, "requirements": [ { "item_id": "N01", "question_type": "Efficacy comparison · Preserved-material preparation", "question": "Is the selected subclaim reduced infection after open-fracture fixation?", "needed": "Distinction between original selected question, subclaim grade/note and parent verdict", "role": "Required", "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score", "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations", "criterion": "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", "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions", "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion", "proposed_research": "Present the original records so the user can read the subclaim separately from parent context", "current_reports": [ "R01" ], "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified", "acquired_read": "Summary read; related external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict", "missingness": "Do not fill subclaim score, status or axes with parent values. No new verdict or boundary certification was written.", "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", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original selected subclaim and parent verdict" }, { "item_id": "N02", "question_type": "Efficacy comparison · Preserved-material preparation", "question": "Can the positive closed-fracture result be applied to open fractures?", "needed": "Materials separating populations and estimated results of the two prespecified cohorts", "role": "Required", "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score", "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations", "criterion": "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", "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions", "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion", "proposed_research": "Present population-specific estimates and applicability side by side", "current_reports": [ "R01" ], "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified", "acquired_read": "Summary read; related external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict", "missingness": "Closed-fracture B with 76 points and -0.8 percentage points cannot be transferred as an open-fracture effect or score.", "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", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original result tables and registration plan for both populations" }, { "item_id": "N03", "question_type": "Efficacy comparison · Preserved-material preparation", "question": "What is the actual denominator for the open-fracture analysis?", "needed": "Open-fracture denominators for recruitment, assignment and analysis populations", "role": "Required", "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score", "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations", "criterion": "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", "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions", "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion", "proposed_research": "Present clusters, people and group-specific analysis denominators separately", "current_reports": [ "R01" ], "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified", "acquired_read": "Summary read; related external material unread", "observation": "The preserved summary gives 1,700 open-fracture patients. The evidence table’s 6,785 and 3,360/3,425 belong to closed fractures.", "condition_status": "Partly verified", "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict", "missingness": "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.", "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", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Open-fracture CONSORT flow and group-specific analysis tables" }, { "item_id": "N04", "question_type": "Efficacy comparison · Preserved-material preparation", "question": "Are open-fracture severity and anatomical scope verified?", "needed": "Open-fracture locations, injury severity, eligibility and exclusion criteria", "role": "Required", "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score", "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations", "criterion": "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", "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions", "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion", "proposed_research": "Present the actual selected population and scope separately in the original report", "current_reports": [ "R01" ], "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified", "acquired_read": "Summary read; related external material unread", "observation": "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.", "condition_status": "Unverified", "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict", "missingness": "Open-fracture classification, contamination, injury location and detailed patient characteristics are unverified within the preserved scope.", "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", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Open-fracture eligibility, baseline characteristics and prespecified subgroup tables" }, { "item_id": "N05", "question_type": "Efficacy comparison · Preserved-material preparation", "question": "What are the two alcohol preparations compared in the trial?", "needed": "Original identities of iodine-alcohol and chlorhexidine-alcohol formulations", "role": "Required", "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score", "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations", "criterion": "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", "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions", "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion", "proposed_research": "Preserve formulation identities and applicability limits", "current_reports": [ "R01" ], "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified", "acquired_read": "Summary read; related external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict", "missingness": "Product, batch, application-process and shared-care details remain unread; equivalence of aqueous iodine or other concentrations is not established.", "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", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial-preparation specifications and original intervention descriptions" }, { "item_id": "N06", "question_type": "Efficacy comparison · Preserved-material preparation", "question": "Can this be extended to other antiseptics or surgeries?", "needed": "Direct evidence matching the actual formulations and surgical context", "role": "Required", "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score", "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations", "criterion": "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", "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions", "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion", "proposed_research": "Express formulation- and surgery-specific results as separate questions", "current_reports": [ "R01" ], "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified", "acquired_read": "Summary read; related external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict", "missingness": "The selected question’s null result does not prove equivalence of every iodine or chlorhexidine preparation.", "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", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct comparison of the same open-fracture population and formulations" }, { "item_id": "N07", "question_type": "Efficacy comparison · Preserved-material preparation", "question": "Are concurrent antibiotics, irrigation and fixation exposures accounted for in the group comparison?", "needed": "Actual surgery, antibiotics, injury care and deviation information by group", "role": "Required", "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score", "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations", "criterion": "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", "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions", "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion", "proposed_research": "Present concurrent exposures and deviations by group", "current_reports": [ "R01" ], "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified", "acquired_read": "Summary read; related external material unread", "observation": "The preserved material describes skin-antiseptic comparisons but no open-fracture-specific antibiotic, irrigation, fixation or other concurrent-exposure details.", "condition_status": "Unverified", "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict", "missingness": "Balance, changes and separation of concurrent-treatment effects remain unverified. No implementation or treatment-change instructions are written.", "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", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Open-fracture shared-care and concurrent-exposure tables" }, { "item_id": "N08", "question_type": "Efficacy comparison · Preserved-material preparation", "question": "What are the randomization unit and alternating-use structure?", "needed": "Design materials distinguishing hospitals, cluster-periods and individuals", "role": "Required", "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score", "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations", "criterion": "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", "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions", "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion", "proposed_research": "Present assignment units separately from participant units", "current_reports": [ "R01" ], "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified", "acquired_read": "Summary read; related external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict", "missingness": "Cluster counts, cluster-periods and patients are different units. Open-fracture recruitment distribution by period is absent from the summary.", "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", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Cluster-period allocation tables and recruitment distribution" }, { "item_id": "N09", "question_type": "Efficacy comparison · Preserved-material preparation", "question": "What is the scope of current evidence on allocation sequence and concealment?", "needed": "Allocation wording in the preserved summary actually read and original methods materials", "role": "Required", "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score", "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations", "criterion": "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", "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions", "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion", "proposed_research": "Present cluster-allocation implementation separately from recruitment timing", "current_reports": [ "R01" ], "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified", "acquired_read": "Summary read; related external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict", "missingness": "Actual concealment processes, advance accessibility and open-fracture recruitment implications remain externally unread.", "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", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original paper allocation methods and operating records" }, { "item_id": "N10", "question_type": "Efficacy comparison · Preserved-material preparation", "question": "Were crossover periods and temporal effects reflected in open-fracture effect estimation?", "needed": "Specifications of period effects, cluster correlation, crossover and analysis model", "role": "Required", "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score", "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations", "criterion": "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", "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions", "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion", "proposed_research": "Present period and cluster handling from the original model", "current_reports": [ "R01" ], "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified", "acquired_read": "Summary read; related external material unread", "observation": "The summary describes two-month alternation but no detailed period/cluster effects or crossover handling in the open-fracture model.", "condition_status": "Unverified", "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict", "missingness": "No new inference is made about analysis of temporal changes, cluster-period correlation or carryover.", "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", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Open-fracture analysis model and prespecified statistical plan" }, { "item_id": "N11", "question_type": "Efficacy comparison · Preserved-material preparation", "question": "What are the SSI definition and ascertainment times?", "needed": "Adjudication criteria and periods for superficial, deep and organ-space infection", "role": "Required", "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score", "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations", "criterion": "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", "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions", "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion", "proposed_research": "Present results by definition, time and infection type", "current_reports": [ "R01" ], "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified", "acquired_read": "Summary read; related external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict", "missingness": "Open-fracture infection subtypes, specific diagnostic documents and event-level ascertainment remain unread in the original report.", "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", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Infection-adjudication manual and open-fracture subtype event tables" }, { "item_id": "N12", "question_type": "Efficacy comparison · Preserved-material preparation", "question": "Are infection-adjudication masking and surgical-team masking distinguished?", "needed": "Masking scope for outcome adjudicators and actual surgical teams", "role": "Required", "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score", "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations", "criterion": "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", "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions", "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion", "proposed_research": "Distinguish masking of outcome adjudication from intervention implementation", "current_reports": [ "R01" ], "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified", "acquired_read": "Summary read; related external material unread", "observation": "The preserved summary records central adjudication unaware of assignment and infeasible surgical-team masking due to preparation characteristics.", "condition_status": "Partly verified", "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict", "missingness": "Missing open-fracture adjudication materials, agreement and reassessment processes remain unread. Perfect masking of everything is not certified.", "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", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Central-adjudication procedures and material flow" }, { "item_id": "N13", "question_type": "Efficacy comparison · Preserved-material preparation", "question": "Can the follow-up completion rate be used as an open-fracture denominator?", "needed": "Open-fracture group-specific follow-up completion, missingness and withdrawal reasons", "role": "Required", "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score", "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations", "criterion": "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", "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions", "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion", "proposed_research": "Present actual open-fracture follow-up and missingness denominators separately", "current_reports": [ "R01" ], "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified", "acquired_read": "Summary read; related external material unread", "observation": "The preserved summary gives 95% primary-analysis follow-up. It does not explicitly state that this sentence applies exclusively to open fractures.", "condition_status": "Partly verified", "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict", "missingness": "Do not calculate open-fracture follow-up numbers from 95% or establish it as the completion rate of every group.", "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", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Population-specific follow-up flow and missing-data handling tables" }, { "item_id": "N14", "question_type": "Efficacy comparison · Preserved-material preparation", "question": "What are the analysis population of interest and assignment basis?", "needed": "Assignment-based analysis principles and actual inclusion/exclusion materials", "role": "Required", "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score", "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations", "criterion": "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", "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions", "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion", "proposed_research": "Distinguish assignment effects from effects of preparations actually received", "current_reports": [ "R01" ], "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified", "acquired_read": "Summary read; related external material unread", "observation": "The preserved analysis sentence describes eligible enrolled patients analyzed according to the antiseptic assigned to their hospital during that crossover period.", "condition_status": "Partly verified", "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict", "missingness": "Actual open-fracture analysis numbers, allocation deviations, preparation changes and inclusion/exclusion reasons are unverified in original materials.", "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", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Open-fracture analysis-population specifications and deviation tables" }, { "item_id": "N15", "question_type": "Efficacy comparison · Preserved-material preparation", "question": "Are infection event counts and group denominators provided for open fractures?", "needed": "Original result tables including each group’s events, denominators and analysis units", "role": "Required", "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score", "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations", "criterion": "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", "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions", "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion", "proposed_research": "Present actual open-fracture events together with analysis denominators", "current_reports": [ "R01" ], "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified", "acquired_read": "Summary read; related external material unread", "observation": "Open-fracture results are summarized as 6.5% versus 7.3%. That summary gives no group event counts or denominators.", "condition_status": "Partly verified", "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict", "missingness": "Do not copy closed-fracture 77/3,360 or 108/3,425 or calculate open-fracture event counts from proportions.", "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", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original open-fracture infection-event and denominator tables" }, { "item_id": "N16", "question_type": "Efficacy comparison · Preserved-material preparation", "question": "How are the open-fracture comparison effect and confidence interval recorded?", "needed": "Effect measure, interval and P value for the selected population", "role": "Required", "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score", "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations", "criterion": "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", "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions", "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion", "proposed_research": "Present the original effect, interval, test and interpretation scope separately", "current_reports": [ "R01" ], "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified", "acquired_read": "Summary read; related external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict", "missingness": "Do not turn a null result with a wide interval into exactly zero effect or proof that the two preparations are equivalent.", "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", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original open-fracture OR results and model explanation" }, { "item_id": "N17", "question_type": "Efficacy comparison · Preserved-material preparation", "question": "Are an open-fracture absolute risk difference and interval available?", "needed": "Directly reported absolute effect and uncertainty for the selected population", "role": "Required", "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score", "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations", "criterion": "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", "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions", "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion", "proposed_research": "If an absolute effect is reported, present the selected population’s value and interval", "current_reports": [ "R01" ], "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified", "acquired_read": "Summary read; related external material unread", "observation": "The preserved summary has open-fracture proportions and OR, but no open-fracture absolute risk difference or its interval.", "condition_status": "Unverified", "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict", "missingness": "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%.", "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", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Directly reported open-fracture absolute-effect table" }, { "item_id": "N18", "question_type": "Efficacy comparison · Preserved-material preparation", "question": "Are open-fracture OR adjustment terms and target effect verified?", "needed": "Open-fracture adjustment model, covariates, cluster handling and effect of interest", "role": "Required", "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score", "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations", "criterion": "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", "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions", "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion", "proposed_research": "Present population-specific estimates’ meaning from the original report", "current_reports": [ "R01" ], "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified", "acquired_read": "Summary read; related external material unread", "observation": "The closed-fracture summary explicitly says adjusted OR; the existing open-fracture counterview records OR 0.86.", "condition_status": "Unverified", "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict", "missingness": "Do not automatically apply closed-fracture adjustment specifications to open fractures or create adjusted effects absent from the original.", "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", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Open-fracture model, estimand and covariate specifications" }, { "item_id": "N19", "question_type": "Efficacy comparison · Preserved-material preparation", "question": "Were the open-fracture population and registration timing distinguished prospectively?", "needed": "Original population distinction, registration contents and dates", "role": "Required", "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score", "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations", "criterion": "Original population distinction, registration contents and dates; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials", "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions", "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion", "proposed_research": "Present connections between population-specific plans and reported results", "current_reports": [ "R01" ], "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified", "acquired_read": "Summary read; related external material unread", "observation": "The summary records closed/open fractures as separate prespecified populations and registration in 2018 before recruitment. The registration number is NCT03523962.", "condition_status": "Partly verified", "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict", "missingness": "Original registration, revision history and detailed open-fracture plans were not read here.", "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", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original NCT03523962 registration and revision history" }, { "item_id": "N20", "question_type": "Efficacy comparison · Preserved-material preparation", "question": "Are analysis plans, multiplicity and infection-subtype hierarchy verified?", "needed": "Protocol, SAP, subtype and population-specific testing plans", "role": "Required", "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score", "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations", "criterion": "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", "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions", "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion", "proposed_research": "Connect the selected population’s prespecified analysis hierarchy with result tables", "current_reports": [ "R01" ], "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified", "acquired_read": "Summary read; related external material unread", "observation": "The preserved summary describes the primary infection endpoint and advance population distinction. It gives no detailed within-open-fracture analysis hierarchy or multiplicity handling.", "condition_status": "Unverified", "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict", "missingness": "Do not establish planning-document existence, contents, agreement or all additional open-fracture analyses.", "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", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Protocol, SAP and endpoint-hierarchy documents" }, { "item_id": "N21", "question_type": "Efficacy comparison · Preserved-material preparation", "question": "Do different closed/open-fracture results prove interaction?", "needed": "Population-specific effects and formal interaction or direct-comparison analyses", "role": "Required", "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score", "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations", "criterion": "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", "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions", "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion", "proposed_research": "Distinguish different-population results from direct tests of differences", "current_reports": [ "R01" ], "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified", "acquired_read": "Summary read; related external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict", "missingness": "Significance in one population and a null result in another do not newly establish interaction or superiority between populations.", "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", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original prespecified population effects and interaction analyses" }, { "item_id": "N22", "question_type": "Efficacy comparison · Preserved-material preparation", "question": "Were the report, registration and related sheets counted as independent repeat trials?", "needed": "Population, bibliography and registration connections in the same PREPARE report", "role": "Required", "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score", "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations", "criterion": "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", "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions", "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion", "proposed_research": "Preserve report slots separately from trial and participant units", "current_reports": [ "R01" ], "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified", "acquired_read": "Summary read; related external material unread", "observation": "The original bibliography is one PREP-IT 2024 paper linked to NCT03523962. Related closed-fracture and selected open-fracture sheets share the parent summary.", "condition_status": "Partly verified", "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict", "missingness": "Do not sum the paper, registration, two populations or related sheets as new independent trials or participant totals. Confirmed independent-trial count remains unrecorded.", "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", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Connections among the same report, registration and populations" }, { "item_id": "N23", "question_type": "Efficacy comparison · Preserved-material preparation", "question": "What evidence supports contrary results in other surgeries?", "needed": "Actual bibliography and populations for clean/contaminated-surgery and cesarean reports", "role": "Required", "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score", "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations", "criterion": "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", "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions", "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion", "proposed_research": "Present other-surgery results only as context for their own populations", "current_reports": [ "R01" ], "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified", "acquired_read": "Summary read; related external material unread", "observation": "The existing counterview mentions results favoring chlorhexidine in clean/contaminated surgeries and cesarean sections.", "condition_status": "Partly verified", "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict", "missingness": "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.", "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", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Identifying materials for other-surgery reports mentioned as context" }, { "item_id": "N24", "question_type": "Efficacy comparison · Preserved-material preparation", "question": "Are long-term results and infection-type follow-up verified for the selected population?", "needed": "Open-fracture infection results by time and long-term clinical outcomes", "role": "Required", "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score", "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations", "criterion": "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", "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions", "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion", "proposed_research": "Present infection-adjudication times separately from long-term clinical follow-up", "current_reports": [ "R01" ], "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified", "acquired_read": "Summary read; related external material unread", "observation": "The preserved summary defines infection adjudication at 30/90 days and separately describes one-year reoperation in safety information.", "condition_status": "Partly verified", "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict", "missingness": "Do not fill open-fracture-specific long-term infection, recovery, reoperation effects or other clinical outcomes with short-term infection rates.", "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", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Open-fracture infection results by time and long-term outcome tables" }, { "item_id": "N25", "question_type": "Efficacy comparison · Preserved-material preparation", "question": "Is the material currently read the full original open-fracture paper?", "needed": "Access distinctions among summary copy, external abstract/full text, registration and plans", "role": "Required", "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score", "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations", "criterion": "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", "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions", "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion", "proposed_research": "Mark summary reading separately from unread external materials", "current_reports": [ "R01" ], "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified", "acquired_read": "Summary read; related external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict", "missingness": "External abstract, full text, registration, protocol and SAP remain unread. URL existence does not establish reading or content certification.", "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", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original report, abstract/full text, registration and plans for the selected population" }, { "item_id": "N26", "question_type": "Efficacy comparison · Preserved-material preparation", "question": "Are public funding and manufacturer-involvement items distinguished?", "needed": "Original research-funding, product-support, outsourced-analysis, medical-writing and publication-cost disclosures", "role": "Required", "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score", "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations", "criterion": "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", "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions", "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion", "proposed_research": "Distinguish reported support from unknown involvement", "current_reports": [ "R01" ], "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified", "acquired_read": "Summary read; related external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict", "missingness": "Scope of unreported disclosures differs from certification of no involvement. Separate open-fracture support, contracts and full COI remain externally unread.", "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", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Funding, product, analysis, writing and publication disclosures and role specifications" }, { "item_id": "N27", "question_type": "Efficacy comparison · Preserved-material preparation", "question": "Are author affiliations, company roles and data control verified?", "needed": "Employee-author, advisory, data-access, design, analysis and publication-role disclosures", "role": "Required", "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score", "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations", "criterion": "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", "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions", "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion", "proposed_research": "Present public funding separately from author-specific independence", "current_reports": [ "R01" ], "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified", "acquired_read": "Summary read; related external material unread", "observation": "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.", "condition_status": "Unverified", "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict", "missingness": "Do not newly certify no company employee authors or no commercial relationships of any kind.", "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", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Author disclosures, contributions and data/publication-rights records" }, { "item_id": "N28", "question_type": "Supplementary harm evidence", "question": "Can one-year reoperation be used as open-fracture harms or efficacy evidence?", "needed": "Actual population, group-specific denominators and definition for that outcome", "role": "Supplementary", "role_reason": "Supplementary condition showing limits of harms/safety information separately from efficacy", "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations", "criterion": "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", "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions", "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion", "proposed_research": "Present reoperation, infection and populations separately", "current_reports": [ "R01" ], "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified", "acquired_read": "Summary read; related external material unread", "observation": "The safety summary describes similar unplanned one-year reoperation: 5.5% versus 5.9%, OR 0.96, 95% CI 0.77–1.20.", "condition_status": "Partly verified", "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict", "missingness": "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.", "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", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Reoperation population, event-definition and group-denominator tables" }, { "item_id": "N29", "question_type": "Supplementary harm evidence", "question": "What is the scope of unreported chemical burns and intraoperative fires?", "needed": "Harms collection, event definitions, exposure and population denominators", "role": "Supplementary", "role_reason": "Supplementary condition showing limits of harms/safety information separately from efficacy", "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations", "criterion": "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", "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions", "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion", "proposed_research": "Present harms-reporting scope together with actual observation denominators", "current_reports": [ "R01" ], "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified", "acquired_read": "Summary read; related external material unread", "observation": "The original safety sentence states that no alcohol-preparation-related chemical burns or intraoperative fires were reported in the overall trial.", "condition_status": "Partly verified", "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict", "missingness": "Do not convert whole-trial nonreporting into zero open-fracture adverse events, no risk or complete collection.", "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", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Harms-collection methods and whole-trial/open-fracture event tables" }, { "item_id": "N30", "question_type": "Supplementary harm evidence", "question": "Are long-term/rare harms and other wound-related events verified?", "needed": "Long-term exposure, follow-up and rare-event materials for the selected population", "role": "Supplementary", "role_reason": "Supplementary condition showing limits of harms/safety information separately from efficacy", "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations", "criterion": "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", "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions", "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion", "proposed_research": "Present long-term harms gaps separately from efficacy", "current_reports": [ "R01" ], "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified", "acquired_read": "Summary read; related external material unread", "observation": "The preserved safety summary contains some reoperation and chemical-burn/fire information, but no complete open-fracture rare-harms or long-term-outcome table.", "condition_status": "Unverified", "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict", "missingness": "Selected-population long-term safety is not established; the historical parent Good safety label is preserved as historical context.", "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", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Selected-population long-term follow-up and event/exposure denominators" }, { "item_id": "N31", "question_type": "Efficacy comparison · Preserved-material preparation", "question": "Are Korean/English prose, axes, reference date and correction history preserved in original form?", "needed": "Copies of parent Korean/English prose, axes, reference date, corrections and original subclaim", "role": "Required", "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score", "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations", "criterion": "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", "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions", "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion", "proposed_research": "Separate existing verdict, dates and corrections from this preparation event", "current_reports": [ "R01" ], "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified", "acquired_read": "Summary read; related external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict", "missingness": "Retain absent subclaim score, status and axes; do not recalculate parent axes or grade as a new selected verdict.", "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", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Preserved original review summary and change-event materials" }, { "item_id": "N32", "question_type": "Efficacy comparison · Preserved-material preparation", "question": "Are historical candidate metadata and current preparation status separated?", "needed": "Distinction between existing selection and preparation, review and independence status", "role": "Required", "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score", "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations", "criterion": "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", "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions", "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion", "proposed_research": "Connect original-record changes separately from preparation and existing content-review events", "current_reports": [ "R01" ], "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified", "acquired_read": "Summary read; related external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict", "missingness": "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.", "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", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Existing selection original and condition/application preparation events" } ], "reports": [ { "report_id": "R01", "title": "PREP-IT Investigators. Skin Antisepsis before Surgical Fixation of Extremity Fractures. N Engl J Med. 2024;390:409-420. PMID: 38294973.", "url": "https://pubmed.ncbi.nlm.nih.gov/38294973/", "report_type": "Preserved summary of trial-paper bibliography", "existence": "Present in the preserved summary’s paper bibliography and research narrative", "acquired_read": "Stored summary read; external abstracts, full texts, registrations and plans unread", "independent_replication": "Connection among preserved reports; not certification of independent replication", "observed_result": "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.", "result_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", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Summary read", "access_status": "Stored summary read", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented" }, { "material_type": "External abstract", "public_status": "Not read", "access_status": "External material unread", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented" }, { "material_type": "External full text", "public_status": "Not read", "access_status": "External material unread", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented" }, { "material_type": "Original registration", "public_status": "Not read", "access_status": "External material unread", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented" }, { "material_type": "Protocol/SAP", "public_status": "Not read", "access_status": "External material unread", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented" } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/38294973/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." } ], "status_dictionary": { "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" }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "Preserve connections among selected open fractures, parent closed fractures, the same paper and registration; different populations are not certified as independent replication" }, "history": [ { "date": "2026-10-13", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public pages and materials were prepared from the existing 32 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-13" }