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

Verdict 2968 · Evidence Check

Stored-material review date: Not recorded  
Original evidence cut-off: 2026-08-26  
Review-criteria version: 1.0  
Public page/material preparation date: 2026-10-13

Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect.

## Assessment scope

- Population: PREPARE participants undergoing fixation of closed lower-extremity or pelvic fractures. Distinguish the 25-hospital US/Canadian cluster-randomized crossover design from 6,785 closed-fracture patients (3,360/3,425). The separate 1,700 open-fracture patients are other-population context in the same report and are not a new summed denominator. Detailed eligibility, baseline risk, period-specific populations and withdrawals/missingness are unverified.
- Ingredient, formulation and route: Specific research preoperative skin-antiseptic preparation containing 0.7% free iodine povacrylex and 74% isopropyl alcohol. Do not transfer the result to all iodine, aqueous formulations, other surgeries or isolated-ingredient effects. No application, dilution, drying, surgery or treatment instructions are created.
- Dose: Concentrations and formulations of the two specific preparations are preserved as original research exposure. Distinguish hospital assignment periods alternating preparations every two months from individual application. Product batches, actual applied amount, adherence/changes and exposure are unverified.
- Comparator: Specific preparation containing 2% chlorhexidine gluconate and 70% isopropyl alcohol. Preserve historical statements of computerized initial hospital assignment, unmasked surgical teams, masked central infection adjudication and analysis by assigned hospital-period preparation. Cluster/period models, concurrent care and actual implementation details are unverified.
- Measured outcome: Primary closed-fracture SSI: superficial incisional infection within 30 days, or deep incisional or organ-space infection within 90 days. Preserve the original numbers separately: 77/3,360 (2.4%) versus 108/3,425 (3.3%); adjusted OR 0.74 (95% CI 0.55–0.999), P=.049; adjusted risk difference -0.8 percentage points (-1.6–0.0). No new RR, proportions, risk difference/NNT, effect or CI is created. Separate open-fracture, one-year reoperation and whole-trial harms reports are not the same estimand as selected infection.
- Duration: Distinguish infection components’ 30/90-day windows from unplanned one-year reoperation. Preserve the original 95% primary follow-up statement without calculating group/endpoint-specific missingness or reusing closed-fracture denominators for reoperation.
- Questions outside this scope: Summing closed/open fractures, hospitals/periods, groups, endpoints or related sheets as new independent trials or participants; Changing a cluster-crossover design into an individually randomized independent trial; Mixing populations, denominators or estimands across 30/90-day infection components, one-year reoperation and whole-trial harms; Converting OR to RR or new risk difference/NNT, or recalculating reported proportions, rounding or CI endpoints; Changing the original borderline-P/CI interpretation into new fragility numbers or efficacy grades; Transferring the specific two-alcohol-preparation comparison to all iodine/aqueous preparations, other surgeries or open fractures; Converting unreported product, analysis, writing or publication-cost support into certification of no support or no COI; Inheriting parent score/axes or historical narratives as subclaim score, current review or original-text reading; New calculations, invented values, effects/CI, grades, independence certification or medication/antisepsis/surgery/treatment implementation guidance

## Checklist items

### N01 · Selected closed-fracture infection question and original values

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The selected existing question is reduced surgical-site infection after closed-fracture fixation; the subclaim B grade is preserved. Parent B with 76 points and axes belong to the original parent prose.
- Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. The selected subclaim has no score, status or axes; parent values are not used to fill them. Existing content review remains incomplete.
- Reason for missing information: The selected subclaim has no score, status or axes; parent values are not used to fill them.
- Required materials and conditions: Selected subclaim B grade/note, parent verdict context and presence of subclaim score, status and axes
- Materials to obtain first: Materials distinguishing the selected subclaim from the parent verdict
- Further research: Proposed update research connecting the original question scope with subsequent materials; no new search, calculation or trial was performed.
- Conditions for verification: Corresponding original materials and analysis scope for selected subclaim B grade/note, parent verdict context and presence of subclaim score, status and axes should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
- Why this condition is needed: Applicability item distinguishing selected subclaim B grade/note, parent verdict context and presence of subclaim score, status and axes and connecting materials needed for the selected question with current materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are custom design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design
- Related sources: S01

### N02 · Closed lower-extremity and pelvic fracture population

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The selected PREPARE result concerns fixation of closed lower-extremity or pelvic fractures within the original-material scope.
- Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Detailed eligibility, fracture characteristics, baseline risk and individual hospital/period distribution are unverified. Existing content review remains incomplete.
- Reason for missing information: Detailed eligibility, fracture characteristics, baseline risk and individual hospital/period distribution are unverified.
- Required materials and conditions: Population, recruitment conditions and population-specific results for closed-fracture fixation
- Materials to obtain first: Recruitment, eligibility, baseline characteristics and closed-fracture analysis-population materials
- Further research: Proposed follow-up research examining reproducibility and heterogeneity within the same population scope; no new search, calculation or trial was performed.
- Conditions for verification: Corresponding original materials and analysis scope for population, recruitment conditions and population-specific results for closed-fracture fixation should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
- Why this condition is needed: Applicability item distinguishing population, recruitment conditions and population-specific results for closed-fracture fixation and connecting materials needed for the selected question with current materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.2.1; Detailed population criteria are designed by CHAMGAP; M03 §3.2.1–3.2.4; Dose, duration and effect-modification details are designed by CHAMGAP; M03 §3.2.2–3.2.3; Reverse labels and test adaptations are designed by CHAMGAP
- Related sources: S01

### N03 · Iodine-alcohol research preparation

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original research preparation contains 0.7% free iodine povacrylex and 74% isopropyl alcohol. This does not stand for aqueous iodine or every iodine preparation.
- Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Original product batches, additional ingredients, applied amount, individual exposure and actual product correspondence are unverified. Existing content review remains incomplete.
- Reason for missing information: Original product batches, additional ingredients, applied amount, individual exposure and actual product correspondence are unverified.
- Required materials and conditions: Identity, concentration and formulation of the iodine preparation used in the trial
- Materials to obtain first: Research preparation identity, batch and exposure records
- Further research: Proposed follow-up research on applicability across formulation differences; no new search, calculation or trial was performed.
- Conditions for verification: Corresponding original materials and analysis scope for identity, concentration and formulation of the iodine preparation used in the trial should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
- Why this condition is needed: Applicability item distinguishing identity, concentration and formulation of the iodine preparation used in the trial and connecting materials needed for the selected question with current materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labels and checking adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed
- Related sources: S01

### N04 · Chlorhexidine-alcohol comparator

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The comparator contains 2% chlorhexidine gluconate and 70% isopropyl alcohol. Do not change this into an isolated iodine-versus-chlorhexidine ingredient comparison.
- Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Products, batches, additional ingredients, individual exposure and equality of conditions beyond the two preparations are unverified. Existing content review remains incomplete.
- Reason for missing information: Products, batches, additional ingredients, individual exposure and equality of conditions beyond the two preparations are unverified.
- Required materials and conditions: Actual comparator preparation and concurrent-exposure scope
- Materials to obtain first: Comparator preparation and actual exposure by group
- Further research: Proposed follow-up research separating differences within the same preparation comparison; no new search, calculation or trial was performed.
- Conditions for verification: Corresponding original materials and analysis scope for actual comparator preparation and concurrent-exposure scope should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
- Why this condition is needed: Applicability item distinguishing actual comparator preparation and concurrent-exposure scope and connecting materials needed for the selected question with current materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.2.2–3.2.3; reverse-direction markers and test adaptation are in-house design; M03 §3.2.3, M08 §8.2.2–8.2.3; in-house application; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is in-house design
- Related sources: S01

### N05 · Research exposure and preoperative antisepsis scope

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The scope is a research comparison of specific alcohol-based antiseptic preparations. This sheet does not create application, dilution, drying or surgical instructions.
- Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Individual application, adherence, preparation changes, discontinuations and surrounding surgical-care details are unverified. Existing content review remains incomplete.
- Reason for missing information: Individual application, adherence, preparation changes, discontinuations and surrounding surgical-care details are unverified.
- Required materials and conditions: Records of research preoperative skin-antisepsis exposure, changes and adherence
- Materials to obtain first: Original planned exposure definitions, actual application and deviation records
- Further research: Proposed follow-up research examining exposure fidelity and attribution of results; no new search, calculation or trial was performed.
- Conditions for verification: Corresponding original materials and analysis scope for records of research preoperative skin-antisepsis exposure, changes and adherence should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
- Why this condition is needed: Applicability item distinguishing records of research preoperative skin-antisepsis exposure, changes and adherence and connecting materials needed for the selected question with current materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.2.2–3.2.3; reverse-direction markers and test adaptation are in-house design; M03 §3.2.3, M08 §8.2.2–8.2.3; in-house application; M04 §4.5–4.6 material collection/selection principles; access/reading separation and the hyperlink scope are in-house design
- Related sources: S01

### N06 · 25-hospital clusters and two-month alternation

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: This was a cluster-randomized crossover trial in 25 US and Canadian hospitals, alternating each hospital’s preparation every two months. Hospitals, periods and patients are not treated as the same randomization unit.
- Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Periods per hospital, participants per period, correlation structure and actual alternation implementation are unverified. Existing content review remains incomplete.
- Reason for missing information: Periods per hospital, participants per period, correlation structure and actual alternation implementation are unverified.
- Required materials and conditions: Hospital and period units of the cluster-randomized crossover design
- Materials to obtain first: Cluster/period allocation tables and cluster analysis plans/materials
- Further research: Proposed follow-up research examining cluster/period heterogeneity and period effects; no new search, calculation or trial was performed.
- Conditions for verification: Corresponding original materials and analysis scope for hospital and period units of the cluster-randomized crossover design should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
- Why this condition is needed: Applicability item distinguishing hospital and period units of the cluster-randomized crossover design and connecting materials needed for the selected question with current materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M08 §8.1–8.2.3; in-house application; M08 §8.2.2, M15 §15.3.1; in-house application; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome connections are in-house application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is in-house design
- Related sources: S01

### N07 · Computer assignment of initial preparation

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The historical original narrative that the Methods Centre assigned initial hospital preparations by computer is preserved.
- Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Original allocation algorithms, timing, access rights, concealment procedures and change history remain unread. Existing content review remains incomplete.
- Reason for missing information: Original allocation algorithms, timing, access rights, concealment procedures and change history remain unread.
- Required materials and conditions: Generation, concealment and responsible roles for initial hospital assignment
- Materials to obtain first: Initial allocation procedures and access/change-history materials
- Further research: Proposed follow-up research examining cluster-allocation procedures and implementation; no new search, calculation or trial was performed.
- Conditions for verification: Corresponding original materials and analysis scope for generation, concealment and responsible roles for initial hospital assignment should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
- Why this condition is needed: Applicability item distinguishing generation, concealment and responsible roles for initial hospital assignment and connecting materials needed for the selected question with current materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M08 §8.1–8.2.3; in-house application; M04 §4.5–4.6 material collection/selection principles; access/reading separation and the hyperlink scope are in-house design; M08 Table 8.2.a, M04 §4.6.3; in-house application
- Related sources: S01

### N08 · Crossover, period and carryover effects

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The same hospitals alternate preparations by period. Crossover periods are not counted as separate independent trials.
- Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Handling of period, sequence, cluster correlation and carryover and actual period-specific analyses are unverified. Existing content review remains incomplete.
- Reason for missing information: Handling of period, sequence, cluster correlation and carryover and actual period-specific analyses are unverified.
- Required materials and conditions: Analysis scope for hospital crossover, periods, sequence and carryover
- Materials to obtain first: Cluster-crossover analysis plans and period-specific results
- Further research: Proposed follow-up analysis research separating period and sequence effects; no new search, calculation or trial was performed.
- Conditions for verification: Corresponding original materials and analysis scope for analysis scope for hospital crossover, periods, sequence and carryover should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
- Why this condition is needed: Applicability item distinguishing analysis scope for hospital crossover, periods, sequence and carryover and connecting materials needed for the selected question with current materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M08 §8.2.2, M15 §15.3.1; in-house application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is in-house design; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome connections are in-house application
- Related sources: S01

### N09 · Surgical-team and central-adjudication masking

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original narrative states that surgical-team masking was infeasible and the primary SSI outcome was adjudicated by a masked central committee.
- Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Actual adjudication materials, maintenance/release of masking, dispute handling and adjudicator-specific procedures are unverified. Existing content review remains incomplete.
- Reason for missing information: Actual adjudication materials, maintenance/release of masking, dispute handling and adjudicator-specific procedures are unverified.
- Required materials and conditions: Masking by role in surgery and infection-outcome adjudication
- Materials to obtain first: Outcome-adjudication criteria, material flow and masking records
- Further research: Proposed follow-up research examining measurement and adjudication bias by role; no new search, calculation or trial was performed.
- Conditions for verification: Corresponding original materials and analysis scope for masking by role in surgery and infection-outcome adjudication should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
- Why this condition is needed: Applicability item distinguishing masking by role in surgery and infection-outcome adjudication and connecting materials needed for the selected question with current materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M08 Table 8.2.a, M03 §3.2.4; CHAMGAP adaptation; Material collection/selection principles in M04 §4.5–4.6; Separating access from reading and defining hyperlink behavior are designed by CHAMGAP
- Related sources: S01

### N10 · 30-day and 90-day infection windows

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The primary endpoint is SSI: superficial incisional infection within 30 days, or deep incisional or organ-space infection within 90 days. Do not relabel every component as a 90-day outcome.
- Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Component-specific events, adjudication times, observation windows and distinctions from delayed/recurrent infection are unverified. Existing content review remains incomplete.
- Reason for missing information: Component-specific events, adjudication times, observation windows and distinctions from delayed/recurrent infection are unverified.
- Required materials and conditions: Infection-component definitions and actual observation times
- Materials to obtain first: Component-specific infection definitions and observation/adjudication materials
- Further research: Proposed follow-up research examining results over time under the same infection definitions; no new search, calculation or trial was performed.
- Conditions for verification: Corresponding original materials and analysis scope for infection-component definitions and actual observation times should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
- Why this condition is needed: Applicability item distinguishing infection-component definitions and actual observation times and connecting materials needed for the selected question with current materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation to each question is internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application
- Related sources: S01

### N11 · Infection measurement and event units

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The selected SSI outcome is connected to the preserved central-adjudication narrative. Infection components or repeated adjudications in one person are not counted as independent participants.
- Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Confirmatory tests, detailed criteria, multiple infections, recurrence, unit-specific aggregation and original data are unverified. Existing content review remains incomplete.
- Reason for missing information: Confirmatory tests, detailed criteria, multiple infections, recurrence, unit-specific aggregation and original data are unverified.
- Required materials and conditions: Infection ascertainment/adjudication criteria and person/event relationships
- Materials to obtain first: Infection-component adjudication and overlap/repetition handling materials
- Further research: Proposed follow-up research distinguishing people from events; no new search, calculation or trial was performed.
- Conditions for verification: Corresponding original materials and analysis scope for infection ascertainment/adjudication criteria and person/event relationships should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
- Why this condition is needed: Applicability item distinguishing infection ascertainment/adjudication criteria and person/event relationships and connecting materials needed for the selected question with current materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is in-house design; M08 Table 8.2.a, M03 §3.2.4; in-house application; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome connections are in-house application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is in-house design
- Related sources: S01

### N12 · 6,785 patients and group-specific infection denominators

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: Original values are retained: 6,785 closed-fracture patients, 3,360/3,425 by group; infection 77/3,360 (2.4%) versus 108/3,425 (3.3%), exactly as reported.
- Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Individual event data, time/component-specific denominators and inclusion/exclusion details are unverified. Proportions, event totals and new effects are not calculated. Existing content review remains incomplete.
- Reason for missing information: Individual event data, time/component-specific denominators and inclusion/exclusion details are unverified. Proportions, event totals and new effects are not calculated.
- Required materials and conditions: Group-specific analysis denominators, events and reported proportions for closed fractures
- Materials to obtain first: Closed-fracture group-specific analysis flow and infection materials
- Further research: Proposed follow-up research reproducing results within the same denominator scope; no new search, calculation or trial was performed.
- Conditions for verification: Corresponding original materials and analysis scope for group-specific analysis denominators, events and reported proportions for closed fractures should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
- Why this condition is needed: Applicability item distinguishing group-specific analysis denominators, events and reported proportions for closed fractures and connecting materials needed for the selected question with current materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design; M08 §8.2.2, M15 §15.3.1; custom application; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application
- Related sources: S01

### N13 · Adjusted OR, CI and P

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: For closed-fracture infection, adjusted OR 0.74, 95% CI 0.55–0.999 and P=.049 are preserved. These are not converted into RR or a new risk difference.
- Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Details of the model, cluster/period handling, covariates and original analysis/code remain unread. Existing content review remains incomplete.
- Reason for missing information: Details of the model, cluster/period handling, covariates and original analysis/code remain unread.
- Required materials and conditions: Adjusted between-group estimate, confidence interval and model
- Materials to obtain first: Original analysis plan, model and adjusted estimates
- Further research: Proposed follow-up research applying the same estimand and analysis scope; no new search, calculation or trial was performed.
- Conditions for verification: Corresponding original materials and analysis scope for adjusted between-group estimate, confidence interval and model should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
- Why this condition is needed: Applicability item distinguishing adjusted between-group estimate, confidence interval and model and connecting materials needed for the selected question with current materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M08 §8.2.2, M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap's own design
- Related sources: S01

### N14 · Adjusted risk difference and units

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: Original adjusted risk difference -0.8 percentage points, 95% CI -1.6–0.0, is retained separately. Do not mix it with the OR interval or revise endpoint rounding.
- Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Original calculation model, precision, output, covariates and cluster/period handling are unverified. Existing content review remains incomplete.
- Reason for missing information: Original calculation model, precision, output, covariates and cluster/period handling are unverified.
- Required materials and conditions: Separate reporting of adjusted risk difference, units and confidence interval
- Materials to obtain first: Risk-difference estimation methods and original outputs
- Further research: Proposed follow-up research examining precision and interpretation by estimand; no new search, calculation or trial was performed.
- Conditions for verification: Corresponding original materials and analysis scope for separate reporting of adjusted risk difference, units and confidence interval should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
- Why this condition is needed: Applicability item distinguishing separate reporting of adjusted risk difference, units and confidence interval and connecting materials needed for the selected question with current materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M15 §15.3.1–15.3.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed.
- Related sources: S01

### N15 · Borderline precision and clinical meaning

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original prose highlights the borderline P=.049 and upper CI limit 0.999. The reported risk-difference CI endpoint 0.0 is also retained.
- Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Prespecified minimum important differences, fragility analyses and detailed original outputs are unverified. No new fragility number, NNT, effect or CI is created. Existing content review remains incomplete.
- Reason for missing information: Prespecified minimum important differences, fragility analyses and detailed original outputs are unverified. No new fragility number, NNT, effect or CI is created.
- Required materials and conditions: Distinction among prespecified important differences, precision and uncertainty
- Materials to obtain first: Prespecified important differences, original analysis and sensitivity materials
- Further research: Proposed follow-up research distinguishing important differences from uncertainty; no new search, calculation or trial was performed.
- Conditions for verification: Corresponding original materials and analysis scope for distinction among prespecified important differences, precision and uncertainty should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
- Why this condition is needed: Applicability item distinguishing distinction among prespecified important differences, precision and uncertainty and connecting materials needed for the selected question with current materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M15 §15.3.1–15.3.3; in-house application; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is in-house design; M03 §3.2.4; in-house extension boundaries
- Related sources: S01

### N16 · Analysis by hospital-period assignment

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original narrative states that the primary analysis followed the preparation assigned to each eligible enrolled patient’s hospital-period. Do not convert this into an individually randomized trial analysis.
- Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Analysis exclusions, crossover application, actual exposure, period-specific results and analysis code are unverified. Existing content review remains incomplete.
- Reason for missing information: Analysis exclusions, crossover application, actual exposure, period-specific results and analysis code are unverified.
- Required materials and conditions: Analysis population and handling according to hospital/period assignment
- Materials to obtain first: Eligible/enrolled/analyzed population flow and hospital-period handling materials
- Further research: Proposed follow-up research examining cluster assignment and actual exposure; no new search, calculation or trial was performed.
- Conditions for verification: Corresponding original materials and analysis scope for analysis population and handling according to hospital/period assignment should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
- Why this condition is needed: Applicability item distinguishing analysis population and handling according to hospital/period assignment and connecting materials needed for the selected question with current materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M08 §8.2.2, M15 §15.3.1; in-house application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is in-house design; M03 §3.2.3, M08 §8.2.2–8.2.3; in-house application
- Related sources: S01

### N17 · 95% primary follow-up and missing data

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original 95% primary follow-up statement is preserved. No group-specific missing-infection counts or individually analyzed denominator for everyone randomized is newly calculated.
- Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Missingness and withdrawal reasons by group/component, follow-up windows, missing-data models and sensitivity materials are unverified. Existing content review remains incomplete.
- Reason for missing information: Missingness and withdrawal reasons by group/component, follow-up windows, missing-data models and sensitivity materials are unverified.
- Required materials and conditions: Follow-up completeness, group-specific missingness/withdrawals and handling
- Materials to obtain first: Group-specific follow-up flow, missingness reasons and handling materials
- Further research: Proposed follow-up research on result uncertainty under missing-data assumptions; no new search, calculation or trial was performed.
- Conditions for verification: Corresponding original materials and analysis scope for follow-up completeness, group-specific missingness/withdrawals and handling should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
- Why this condition is needed: Applicability item distinguishing follow-up completeness, group-specific missingness/withdrawals and handling and connecting materials needed for the selected question with current materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application
- Related sources: S01

### N18 · NCT identifier and preregistration history

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original registration identifier is NCT03523962. Registration before recruitment and the existing Korean narrative’s 2018 registration statement are preserved; the stored English summary is retained as well.
- Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Registration full text/history, protocol/SAP and comparisons with recruitment/analysis timing remain unread here. Existing content review remains incomplete.
- Reason for missing information: Registration full text/history, protocol/SAP and comparisons with recruitment/analysis timing remain unread here.
- Required materials and conditions: Original registration, prespecified endpoints/analyses and change history
- Materials to obtain first: Original registration history, protocol and SAP
- Further research: Proposed follow-up research linking prespecified plans with reported results; no new search, calculation or trial was performed.
- Conditions for verification: Corresponding original materials and analysis scope for original registration, prespecified endpoints/analyses and change history should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
- Why this condition is needed: Applicability item distinguishing original registration, prespecified endpoints/analyses and change history and connecting materials needed for the selected question with current materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M08 Table 8.2.a, M04 §4.6.3; custom application; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design
- Related sources: S01

### N19 · Prespecified closed/open population distinction

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original advance distinction between closed-fracture and separate open-fracture analyses is preserved. The selected closed-fracture B grade is not transferred to open-fracture results.
- Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Detailed original advance plans, interactions, multiplicity handling and analysis hierarchy are unverified. Existing content review remains incomplete.
- Reason for missing information: Detailed original advance plans, interactions, multiplicity handling and analysis hierarchy are unverified.
- Required materials and conditions: Prespecification of closed/open analyses and multiple-comparison scope
- Materials to obtain first: Original planned population analyses and multiplicity materials
- Further research: Proposed follow-up research on population-specific estimates and interactions; no new search, calculation or trial was performed.
- Conditions for verification: Corresponding original materials and analysis scope for prespecification of closed/open analyses and multiple-comparison scope should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
- Why this condition is needed: Applicability item distinguishing prespecification of closed/open analyses and multiple-comparison scope and connecting materials needed for the selected question with current materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M08 Table 8.2.a, M04 §4.6.3; internal application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed.
- Related sources: S01

### N20 · Open-fracture results as separate context

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: Separate open-fracture results for 1,700 patients are linked as preserved context: 6.5% versus 7.3%, OR 0.86 (95% CI 0.58–1.27), P=.45. Do not create them as the selected closed-fracture result or a new report.
- Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Group-specific open-fracture denominators, events, detailed analyses and direct comparison with closed-fracture results are unverified. The two populations are not newly summed. Existing content review remains incomplete.
- Reason for missing information: Group-specific open-fracture denominators, events, detailed analyses and direct comparison with closed-fracture results are unverified. The two populations are not newly summed.
- Required materials and conditions: Relationship between open-fracture results in the same report and the selected question
- Materials to obtain first: Population-specific analysis and denominator materials from the same report
- Further research: Proposed follow-up research separating population-specific differences; no new search, calculation or trial was performed.
- Conditions for verification: Corresponding original materials and analysis scope for relationship between open-fracture results in the same report and the selected question should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
- Why this condition is needed: Applicability item distinguishing relationship between open-fracture results in the same report and the selected question and connecting materials needed for the selected question with current materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is in-house design; M03 §3.2.1; detailed population conditions are in-house design; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome connections are in-house application; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are in-house design
- Related sources: S01

### N21 · Contrary materials from other surgeries/formulations

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original context mentions results favoring chlorhexidine in other clean/contaminated surgeries and cesarean trials. Do not transfer them to the same direct comparison of the selected preparation in closed fractures.
- Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Individual bibliographies, preparations, populations and estimates for those reports are not connected in the current preserved summary and remain unverified. Existing content review remains incomplete.
- Reason for missing information: Individual bibliographies, preparations, populations and estimates for those reports are not connected in the current preserved summary and remain unverified.
- Required materials and conditions: Identity, populations and comparison relationships of other-surgery/formulation results
- Materials to obtain first: Each mentioned report and formulation/surgery-specific materials
- Further research: Proposed follow-up research distinguishing results from different surgeries/formulations; no new search, calculation or trial was performed.
- Conditions for verification: Corresponding original materials and analysis scope for identity, populations and comparison relationships of other-surgery/formulation results should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
- Why this condition is needed: Applicability item distinguishing identity, populations and comparison relationships of other-surgery/formulation results and connecting materials needed for the selected question with current materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is in-house design; M03 §3.2.2–3.2.3; reverse-direction markers and test adaptation are in-house design; M03 §3.2.1; detailed population conditions are in-house design; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are in-house design
- Related sources: S01

### N22 · Concurrent surgical care and attribution

Verification status: Unverified  
Reading scope: Summary read; external material unread

- Current findings: The original scope is a comparison of specific skin-antiseptic preparations.
- Why unverified: Information currently required is unverified in the preserved summary. Antibiotics, surgery/wound care, fixation characteristics, other institutional exposures and adherence/change materials are unverified. No new care or treatment instructions are provided. Existing content review remains incomplete.
- Reason for missing information: Antibiotics, surgery/wound care, fixation characteristics, other institutional exposures and adherence/change materials are unverified. No new care or treatment instructions are provided.
- Required materials and conditions: Concurrent exposures and actual care differences between groups
- Materials to obtain first: Group-specific concurrent-exposure/care and adherence records
- Further research: Proposed follow-up research examining concurrent exposures and attribution to preparations; no new search, calculation or trial was performed.
- Conditions for verification: Corresponding original materials and analysis scope for concurrent exposures and actual care differences between groups should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
- Why this condition is needed: Applicability item distinguishing concurrent exposures and actual care differences between groups and connecting materials needed for the selected question with current materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; custom application; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are custom design; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are custom design
- Related sources: S01

### N23 · Overlap among reports, hospitals and people

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: Closed/open populations, hospital crossover, infection components and one-year reoperation in one PREPARE bibliography are distinguished. Hospitals, periods, groups, endpoints and related sheets are not summed as independent trials or participants.
- Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. External comparisons of patient overlap, period-specific flow, individual subsequent-report correspondence and independence are unverified. Existing content review remains incomplete.
- Reason for missing information: External comparisons of patient overlap, period-specific flow, individual subsequent-report correspondence and independence are unverified.
- Required materials and conditions: Relationships among the same report, clusters, periods, populations and subsequent endpoints
- Materials to obtain first: Report-cluster-period-population-endpoint relationship materials
- Further research: Proposed follow-up research connecting bibliography with actual trial/population relationships; no new search, calculation or trial was performed.
- Conditions for verification: Corresponding original materials and analysis scope for relationships among the same report, clusters, periods, populations and subsequent endpoints should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
- Why this condition is needed: Applicability item distinguishing relationships among the same report, clusters, periods, populations and subsequent endpoints and connecting materials needed for the selected question with current materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome connections are in-house application; M04 §4.6.1–4.6.2, M15 §15.3.1; in-house application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is in-house design
- Related sources: S01

### N24 · PCORI and CIHR funding

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: Original funding statements concerning PCORI and the Canadian Institutes of Health Research are preserved.
- Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Contracts, roles, analysis/prose/publication involvement and original funding/COI materials remain unread. Existing content review remains incomplete.
- Reason for missing information: Contracts, roles, analysis/prose/publication involvement and original funding/COI materials remain unread.
- Required materials and conditions: Original funders and separate support roles
- Materials to obtain first: Funding contracts, funder roles and original disclosures
- Further research: Proposed follow-up research distinguishing support roles and report relationships; no new search, calculation or trial was performed.
- Conditions for verification: Corresponding original materials and analysis scope for original funders and separate support roles should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
- Why this condition is needed: Applicability item distinguishing original funders and separate support roles and connecting materials needed for the selected question with current materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design
- Related sources: S01

### N25 · University operational roles

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: Operational roles of McMaster University and the University of Maryland Baltimore are preserved within the original narrative scope.
- Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Institution/author-specific roles and detailed analysis/writing/publication involvement are unverified. Institution names alone do not certify independence. Existing content review remains incomplete.
- Reason for missing information: Institution/author-specific roles and detailed analysis/writing/publication involvement are unverified. Institution names alone do not certify independence.
- Required materials and conditions: Operating institutions and funding/product-provision roles
- Materials to obtain first: Operational, author-contribution and disclosure materials
- Further research: Proposed follow-up research examining operational roles and result-reporting relationships; no new search, calculation or trial was performed.
- Conditions for verification: Corresponding original materials and analysis scope for operating institutions and funding/product-provision roles should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
- Why this condition is needed: Applicability item distinguishing operating institutions and funding/product-provision roles and connecting materials needed for the selected question with current materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design
- Related sources: S01

### N26 · Manufacturer and product/writing-support gaps

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original statement that manufacturer product donation, analysis, medical writing and publication-cost support were not reported is preserved.
- Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Nonreporting is not converted into no support, no employee authors, no COI or verified independence. Detailed disclosures remain unread. Existing content review remains incomplete.
- Reason for missing information: Nonreporting is not converted into no support, no employee authors, no COI or verified independence. Detailed disclosures remain unread.
- Required materials and conditions: Separate disclosures of product donation, analysis, writing, publication costs, employee authors and COI
- Materials to obtain first: Individual original disclosures of products, analysis, writing, publication costs, employee involvement and COI
- Further research: Proposed follow-up research distinguishing reporting gaps for each support/relationship; no new search, calculation or trial was performed.
- Conditions for verification: Corresponding original materials and analysis scope for separate disclosures of product donation, analysis, writing, publication costs, employee authors and COI should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
- Why this condition is needed: Applicability item distinguishing separate disclosures of product donation, analysis, writing, publication costs, employee authors and COI and connecting materials needed for the selected question with current materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design
- Related sources: S01

### N27 · One-year reoperation as an additional endpoint

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: Unplanned one-year reoperation is preserved within the reported scope: 5.5% versus 5.9%, OR 0.96 (95% CI 0.77–1.20). Do not convert it into the same 30/90-day infection outcome or primary efficacy.
- Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Reoperation population, group denominators, events, definition and analysis hierarchy are unspecified; closed-fracture denominators are not reused. Existing content review remains incomplete.
- Reason for missing information: Reoperation population, group denominators, events, definition and analysis hierarchy are unspecified; closed-fracture denominators are not reused.
- Required materials and conditions: Separation of reoperation timing, definition, population and denominator from primary infection
- Materials to obtain first: Reoperation population, denominator, definition and analysis materials
- Further research: Proposed follow-up research distinguishing infection from subsequent reoperation; no new search, calculation or trial was performed.
- Conditions for verification: Corresponding original materials and analysis scope for separation of reoperation timing, definition, population and denominator from primary infection should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
- Why this condition is needed: Applicability item distinguishing separation of reoperation timing, definition, population and denominator from primary infection and connecting materials needed for the selected question with current materials.
- Application exceptions: Supplement the selected subclaim’s safety-material gaps. Functional-status/infection efficacy results or parent safety wording do not establish safety or create harms rates or new usage instructions.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is in-house design; M08 Table 8.2.a, M04 §4.6.3; in-house application; M19 §19.1.2–19.2.4; in-house application; M19 §19.1.2–19.2.4; in-house application; M19 §19.1.2–19.2.4; in-house application
- Related sources: S01

### N28 · Whole-trial burn/fire narrative

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The preserved summary scope states that no alcohol-related chemical burns or operating-room fires were reported in the overall trial.
- Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Nonreporting is not converted into zero events, complete collection, all safety or closed-fracture-only safety certification. Detailed collection/populations/denominators are unverified. Existing content review remains incomplete.
- Reason for missing information: Nonreporting is not converted into zero events, complete collection, all safety or closed-fracture-only safety certification. Detailed collection/populations/denominators are unverified.
- Required materials and conditions: Harms collection/reporting scope, populations, periods and denominators
- Materials to obtain first: Harms collection criteria, populations, denominators and event/discontinuation materials
- Further research: Proposed research on harms-reporting scope and subsequent safety materials; no new search, calculation or trial was performed.
- Conditions for verification: Corresponding original materials and analysis scope for harms collection/reporting scope, populations, periods and denominators should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
- Why this condition is needed: Applicability item distinguishing harms collection/reporting scope, populations, periods and denominators and connecting materials needed for the selected question with current materials.
- Application exceptions: Supplement the selected subclaim’s safety-material gaps. Functional-status/infection efficacy results or parent safety wording do not establish safety or create harms rates or new usage instructions.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M19 §19.1.2–19.2.4; detailed distinctions are custom design; M19 §19.1.2–19.2.4; custom application; M19 §19.1.2–19.2.4, M04 §4.6.3; custom application; M19 §19.1.2–19.2.4; custom application; M19 §19.1.2–19.2.4; custom application
- Related sources: S01

### N29 · Generalization to other formulations/settings

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original result compares two specific alcohol-based preparations in closed-fracture fixation. Do not generalize to all iodine preparations, aqueous preparations, other surgeries or open fractures.
- Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Other formulations, hospital/era settings, vulnerable populations and long-term outcomes are unverified. Existing content review remains incomplete.
- Reason for missing information: Other formulations, hospital/era settings, vulnerable populations and long-term outcomes are unverified.
- Required materials and conditions: Applicability beyond the selected preparation, surgery and fracture conditions
- Materials to obtain first: Additional materials by population, formulation and surgery
- Further research: Proposed follow-up research distinguishing the same question from different conditions; no new search, calculation or trial was performed.
- Conditions for verification: Corresponding original materials and analysis scope for applicability beyond the selected preparation, surgery and fracture conditions should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
- Why this condition is needed: Applicability item distinguishing applicability beyond the selected preparation, surgery and fracture conditions and connecting materials needed for the selected question with current materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.2.1–3.2.4; dose, duration and effect-modification details are in-house design; M03 §3.2.2–3.2.3; reverse-direction markers and test adaptation are in-house design; M03 §3.2.1; detailed population conditions are in-house design; M03 §3.2.4; in-house extension boundaries
- Related sources: S01

### N30 · Existing axes, Korean/English prose and dates/corrections

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: Parent B with 76 points, existing axes, Korean/English prose, 2026-08-26, the empty corrections array and deliberation string, and selected subclaim B grade/note are preserved in original form in the complete summary. Absent subclaim score/status/axes and parent classification fields are not filled.
- Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Historical cross-checks and registration/review narratives are not current original-text reading, completed review or certification of fulfilled conditions. New evidence currency is unverified. Existing content review remains incomplete.
- Reason for missing information: Historical cross-checks and registration/review narratives are not current original-text reading, completed review or certification of fulfilled conditions. New evidence currency is unverified.
- Required materials and conditions: Distinction among original subclaim, parent verdict and historical records
- Materials to obtain first: Original verdict/corrections, changed prose and user comments
- Further research: Proposed updating research distinguishing original-material changes from preparation versions; no new search, calculation or trial was performed.
- Conditions for verification: Corresponding original materials and analysis scope for distinction among original subclaim, parent verdict and historical records should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
- Why this condition is needed: Applicability item distinguishing distinction among original subclaim, parent verdict and historical records and connecting materials needed for the selected question with current materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed
- Related sources: S01

### N31 · Actual summary reading and unread external materials

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The preserved summary was read for preparation and PREPARE bibliography/URL linked. External papers, registration, protocol, SAP and funding/COI originals remain unread, with no access attempted.
- Why unverified: Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Bibliographic links or original registration numbers do not elevate external acquisition, reading or review status. External click/link checks were not performed. Existing content review remains incomplete.
- Reason for missing information: Bibliographic links or original registration numbers do not elevate external acquisition, reading or review status. External click/link checks were not performed.
- Required materials and conditions: Actual reading, identity, URLs and needed additional materials by source
- Materials to obtain first: Original paper, registration history, protocol/SAP, individual disclosures and existing content-review comments
- Further research: A research proposal for scope-specific updates based on actually acquired material; no new investigation, calculation or trial is performed in this conversion.
- Conditions for verification: Corresponding original materials and analysis scope for actual reading, identity, URLs and needed additional materials by source should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
- Why this condition is needed: Applicability item distinguishing actual reading, identity, URLs and needed additional materials by source and connecting materials needed for the selected question with current materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design
- Related sources: S01

## Evidence and sources

### S01

PREP-IT Investigators. 2024 PREPARE Closed

[PubMed](https://pubmed.ncbi.nlm.nih.gov/38294973/)

Materials actually read: Summary read; external material unread  
Findings recorded in the summary: 2.4% versus 3.3%; adjusted OR 0.74 (95% CI 0.55–0.999), P=0.049; risk difference -0.8 percentage points (-1.6–0.0). Grade B. In 6,785 closed-fracture patients, SSI was 77/3,360 (2.4%) versus 108/3,425 (3.3%): adjusted OR 0.74 (95% CI 0.55–0.999), P=0.049; adjusted risk difference -0.8 percentage points (95% CI -1.6–0.0). The original interpretation states that the P value and upper CI limit were extremely borderline, so a small difference could have made the result null.  
Record level: Outcome wording in the stored summary  
Independent replication: S01 PREPARE is a cluster-randomized crossover report from 25 US/Canadian hospitals alternating preparations every two months. Preserve closed lower-extremity/pelvic fracture values separately: 6,785 patients (3,360/3,425), infection 77/3,360 (2.4%) versus 108/3,425 (3.3%), adjusted OR 0.74 (0.55–0.999), P=.049, and original adjusted risk difference -0.8 percentage points (-1.6–0.0). Distinguish superficial 30-day and deep/organ-space 90-day infection windows from separate 1,700 open-fracture patients, one-year reoperation and whole-trial harms narratives. Do not sum the same hospitals/periods, populations, people, groups, infection components, bibliography or related sheets as new independent trials or participants. Report/material-slot counts are not unique clinical-trial, participant or independent-replication totals; no new sums or independence certification are created.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| Stored summary | Stored file | Stored summary | Summary read | Only stored-summary and bibliographic content was used for production. External material verification/review is not complete. |
| External paper | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |
| Registration material | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |
| Protocol | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |
| Statistical analysis plan | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |
| Funding, product-support and COI material | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |

## Review criteria and methods

These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score.

- M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · Preserved method HTML copies; no current method-content re-review or official tool execution
- M04 [Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · Preserved method HTML copies; no current method-content re-review or official tool execution
- M08 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · Preserved method HTML copies; no current method-content re-review or official tool execution
- M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · Preserved method HTML copies; no current method-content re-review or official tool execution
- M19 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · Preserved method HTML copies; no current method-content re-review or official tool execution

## What the statuses mean

- Met: Status for necessary evidence confirmed after existing content review. No completion is declared in the current presentation.
- Partly verified: Some information in the stored summary is linked into the table. External comparison/content review is not complete.
- Unverified: The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.
- Review incomplete: Existing content review remains incomplete.
- Not reported: Not reported within the stored material actually read; not extended to the entire primary paper.
- Inaccessible: Means an actual access failure. Access not attempted here is not assigned this state.
- Not applicable: Not used as a substitute for an evidence gap.
- Conflicting data: Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.
- Insufficient evidence for the conditions: Marks a gap in additional material required by the selected conditions; not a new efficacy grade.

## Change history

2026-10-13 · Public page/materials 1.0. A public view and materials were prepared from the existing31 items. No new clinical search, verification-status change or scoring was performed.