# Twenty-four-hour antibiotic prophylaxis × Noninferior 90-day SSI — Evidence sheet distinguishing the prespecified margin and denominators Verdict 2934 · 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: 2026-10-10 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: Patients undergoing open cystectomy and urinary diversion at a single Swiss center; original eligibility and baseline details remain unread - Ingredient, formulation and route: Historical study condition of stopping prophylactic antibiotics 24 hours after surgery; not instructions on duration or use - Dose: Drug-combination, dose and concomitant-use details remain unread; no individual antibiotic choice, use or stopping guidance is generated - Comparator: Prophylactic antibiotics continued until catheter and stent removal; original median 8 days - Measured outcome: Noninferior 90-day CDC-defined SSI; preserving the original 10%p margin, 90% CI and 193-participant PP analysis - Duration: Original SSI and mortality at 90 days; prophylaxis duration of 1 day (IQR1~1) versus 8 days (IQR7~10) is a historical exposure statistic - Questions outside this scope: Converting noninferiority into SSI superiority or exact equivalence; Converting median exposure into mean total exposure or the same reduction for each individual; Converting exposure or mechanism into direct reductions in resistance, costs or all harms; Certifying 193-participant PP as all-randomized 196-participant ITT or as the exposure denominator; Recommendations on antibiotic type, duration, use, stopping or treatment substitution ## Checklist items ### N01 · Are the original subclaim and grade distinguished from the parent judgment context? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The selected claim is noninferior 90-day surgical-site infection, with subclaim grade C and a note that the prespecified 10%p margin was met. The parent verdict is C, 56 points, Caution. - Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Absent subclaim score, status and axes are not filled with parent values. This production does not establish a new verdict or grade certification. - Reason for missing information: Absent subclaim score, status and axes are not filled with parent values. This production does not establish a new verdict or grade certification. - Required materials and conditions: Separate records of the selected subclaim, grade and note, and the original parent verdict - Materials to obtain first: Absent subclaim score, status and axes are not filled with parent values. This production does not establish a new verdict or grade certification. - Further research: Link additional materials separately to the relevant subclaim and parent context. - Conditions for verification: Separate records of the selected subclaim, grade and note, and the original parent verdict - Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits - Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Noninferior 90-day surgical-site infection - Related sources: R01 ### N02 · What surgery, population and center were actually studied? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: PAPRAC included patients undergoing open cystectomy and urinary diversion at a single Swiss center. - Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. The preserved summary lacks detailed tables of age, eligibility exclusions, baseline risk and surgical details. Results are not automatically extended to robotic surgery or other populations. - Reason for missing information: The preserved summary lacks detailed tables of age, eligibility exclusions, baseline risk and surgical details. Results are not automatically extended to robotic surgery or other populations. - Required materials and conditions: Eligibility, surgery type, urinary diversion, baseline characteristics and denominators - Materials to obtain first: The preserved summary lacks detailed tables of age, eligibility exclusions, baseline risk and surgical details. Results are not automatically extended to robotic surgery or other populations. - Further research: Obtain the original eligibility, baseline characteristics, surgery, center and denominator records. - Conditions for verification: Eligibility, surgery type, urinary diversion, baseline characteristics and denominators - Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits - Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Noninferior 90-day surgical-site infection - Related sources: R01 ### N03 · What were the historical intervention and comparator exposure until catheter and stent removal? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original study conditions were stopping prophylactic antibiotics 24 hours after surgery in the short arm and continuing until catheter and stent removal in the extended arm. - Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. No individual antibiotic type, duration, use or stopping recommendation is made. Details of exact drug combinations, doses, concomitant drugs and additional treatment exposure remain unread. - Reason for missing information: No individual antibiotic type, duration, use or stopping recommendation is made. Details of exact drug combinations, doses, concomitant drugs and additional treatment exposure remain unread. - Required materials and conditions: Original intervention, comparator, stopping criteria, actual exposure and accompanying care - Materials to obtain first: No individual antibiotic type, duration, use or stopping recommendation is made. Details of exact drug combinations, doses, concomitant drugs and additional treatment exposure remain unread. - Further research: Obtain the original arm-specific tables of drugs, prophylactic and treatment exposure, actual duration and accompanying care. - Conditions for verification: Original intervention, comparator, stopping criteria, actual exposure and accompanying care - Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits - Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Noninferior 90-day surgical-site infection - Related sources: R01 ### N04 · Are 196 randomized participants distinguished from 193 in the primary analysis and denominators 95/98? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: After 196 participants were randomized, the prespecified per-protocol primary analysis included 193 (95/98), excluding 3 canceled surgeries. - Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. The summary lacks original arm-specific randomized counts, cancellations by arm and additional follow-up losses. No new totals, dropout rates or certification of an all-randomized ITT analysis are produced. - Reason for missing information: The summary lacks original arm-specific randomized counts, cancellations by arm and additional follow-up losses. No new totals, dropout rates or certification of an all-randomized ITT analysis are produced. - Required materials and conditions: Arm-specific randomization, canceled surgery, analysis and follow-up flow - Materials to obtain first: The summary lacks original arm-specific randomized counts, cancellations by arm and additional follow-up losses. No new totals, dropout rates or certification of an all-randomized ITT analysis are produced. - Further research: Obtain the original participant flow, exclusion reasons, arm-specific allocation and analysis counts, and missing-data tables. - Conditions for verification: Arm-specific randomization, canceled surgery, analysis and follow-up flow - Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits - Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Noninferior 90-day surgical-site infection - Related sources: R01 ### N05 · Are the open-label design and infection adjudicators' roles distinguished? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original design was a single-center open-label noninferiority randomized trial. The record states that infectious-disease specialists and clinicians not involved in care adjudicated 90-day CDC-defined SSI. - Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Non-involvement in care is not newly certified as blinding to allocation. Details of allocation concealment, assessor blinding and analyst independence remain unread. - Reason for missing information: Non-involvement in care is not newly certified as blinding to allocation. Details of allocation concealment, assessor blinding and analyst independence remain unread. - Required materials and conditions: Allocation, concealment, measurement, adjudicator and analyst procedures - Materials to obtain first: Non-involvement in care is not newly certified as blinding to allocation. Details of allocation concealment, assessor blinding and analyst independence remain unread. - Further research: Obtain the original allocation, adjudication, blinding and analysis procedures. - Conditions for verification: Allocation, concealment, measurement, adjudicator and analyst procedures - Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits - Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Noninferior 90-day surgical-site infection - Related sources: R01 ### N06 · What is the actual access status of registration, protocol and analysis-plan materials? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The registration identifier in the original evidence list is NCT03305627. The preserved summary records a prespecified per-protocol primary analysis and a prespecified 10%p margin. - Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. No new URL was constructed from the registration identifier, and registration, full text and plans were not read. Details of the original primary/secondary exposure hierarchy and testing plan remain unread. - Reason for missing information: No new URL was constructed from the registration identifier, and registration, full text and plans were not read. Details of the original primary/secondary exposure hierarchy and testing plan remain unread. - Required materials and conditions: Original registration, protocol, SAP, outcome hierarchy and amendment history - Materials to obtain first: No new URL was constructed from the registration identifier, and registration, full text and plans were not read. Details of the original primary/secondary exposure hierarchy and testing plan remain unread. - Further research: Obtain the original registration, plans, analysis populations, hierarchy, amendments and multiplicity information. - Conditions for verification: Original registration, protocol, SAP, outcome hierarchy and amendment history - Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits - Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Noninferior 90-day surgical-site infection - Related sources: R01 ### N07 · What direct outcome is 90-day CDC-defined SSI? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The selected question is noninferiority for CDC-defined surgical-site infection within 90 days. Infectious-disease specialists and clinicians not involved in care adjudicated the outcome. - Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. The summary lacks detailed definitions and results for superficial, deep and organ-space categories, and visit schedules. Other infection or wound measures are not substituted. - Reason for missing information: The summary lacks detailed definitions and results for superficial, deep and organ-space categories, and visit schedules. Other infection or wound measures are not substituted. - Required materials and conditions: Infection definition, categories, ascertainment, time points and denominators - Materials to obtain first: The summary lacks detailed definitions and results for superficial, deep and organ-space categories, and visit schedules. Other infection or wound measures are not substituted. - Further research: Obtain the original CDC definitions, classification, ascertainment, results by time point and denominators. - Conditions for verification: Infection definition, categories, ascertainment, time points and denominators - Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits - Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Noninferior 90-day surgical-site infection - Related sources: R01 ### N08 · Are arm-specific SSI events 8/95 and 12/98 and original percentages preserved? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original materials record 90-day SSI as 8/95 (8.4%) in the short arm versus 12/98 (12.2%) in the extended arm. - Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. People, repeated events, original denominators and all infections are not mixed. No new percentages, RR, event totals, P values or CI are calculated. - Reason for missing information: People, repeated events, original denominators and all infections are not mixed. No new percentages, RR, event totals, P values or CI are calculated. - Required materials and conditions: Arm-specific events, people, denominators, original percentages and time window - Materials to obtain first: People, repeated events, original denominators and all infections are not mixed. No new percentages, RR, event totals, P values or CI are calculated. - Further research: Obtain the original event tables, arm-specific denominators, repeated-infection records and analysis definitions. - Conditions for verification: Arm-specific events, people, denominators, original percentages and time window - Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits - Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Noninferior 90-day surgical-site infection - Related sources: R01 ### N09 · Are the risk-difference direction and 90% CI preserved as originally recorded? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original SSI risk difference is −3.8%p (90% CI −11.1~3.4). - Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. 90% is not changed to 95%. No new reverse-direction effect, risk ratio, test P value or adjusted model is produced. Details of the original risk-difference calculation remain unread. - Reason for missing information: 90% is not changed to 95%. No new reverse-direction effect, risk ratio, test P value or adjusted model is produced. Details of the original risk-difference calculation remain unread. - Required materials and conditions: Risk difference of interest, arm order, CI level and original model - Materials to obtain first: 90% is not changed to 95%. No new reverse-direction effect, risk ratio, test P value or adjusted model is produced. Details of the original risk-difference calculation remain unread. - Further research: Obtain the original comparison direction, risk-difference model, CI calculation and denominators. - Conditions for verification: Risk difference of interest, arm order, CI level and original model - Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits - Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Noninferior 90-day surgical-site infection - Related sources: R01 ### N10 · Are the prespecified 10%p noninferiority margin and scope of the original conclusion distinguished? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original materials state that the prespecified 10%p noninferiority margin was met, with 90% CI −11.1~3.4. - Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. No new certification is made without reading the clinical margin rationale, original assumptions, α, test P value and plans. No new margin or examples of allowable events are produced. - Reason for missing information: No new certification is made without reading the clinical margin rationale, original assumptions, α, test P value and plans. No new margin or examples of allowable events are produced. - Required materials and conditions: Margin, direction, rationale, prespecification, CI and plans - Materials to obtain first: No new certification is made without reading the clinical margin rationale, original assumptions, α, test P value and plans. No new margin or examples of allowable events are produced. - Further research: Obtain the margin rationale, prespecification, testing and analysis plans, and original CI. - Conditions for verification: Margin, direction, rationale, prespecification, CI and plans - Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits - Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Noninferior 90-day surgical-site infection - Related sources: R01 ### N11 · Has noninferiority been kept separate from superiority for reducing infection and exact equivalence? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original trial used a noninferiority design and records SSI risk difference −3.8%p and 90% CI −11.1~3.4. - Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. The direction of the original percentages alone does not establish superiority for reducing infection or equivalence with exactly no difference. - Reason for missing information: The direction of the original percentages alone does not establish superiority for reducing infection or equivalence with exactly no difference. - Required materials and conditions: Original design, effect, interval, hypothesis and interpretation - Materials to obtain first: The direction of the original percentages alone does not establish superiority for reducing infection or equivalence with exactly no difference. - Further research: Link the original hypothesis, interval, margin and effect interpretation to the relevant question. - Conditions for verification: Original design, effect, interval, hypothesis and interpretation - Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits - Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Noninferior 90-day surgical-site infection - Related sources: R01 ### N12 · Are the per-protocol primary analysis and gaps in ITT and sensitivity analyses distinguished? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The prespecified per-protocol primary analysis included 193 participants after excluding 3 canceled surgeries. - Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. This analysis is not converted into an ITT analysis of all 196 randomized participants. Details of ITT, sensitivity analyses, arm-specific cancellations, losses and original analysis mapping are unavailable. - Reason for missing information: This analysis is not converted into an ITT analysis of all 196 randomized participants. Details of ITT, sensitivity analyses, arm-specific cancellations, losses and original analysis mapping are unavailable. - Required materials and conditions: Original PP, ITT, cancellation, adherence, missingness and sensitivity-analysis definitions - Materials to obtain first: This analysis is not converted into an ITT analysis of all 196 randomized participants. Details of ITT, sensitivity analyses, arm-specific cancellations, losses and original analysis mapping are unavailable. - Further research: Obtain the original PP/ITT definitions, exclusions, adherence, missing-data assumptions, sensitivity analyses and original CI. - Conditions for verification: Original PP, ITT, cancellation, adherence, missingness and sensitivity-analysis definitions - Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits - Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Noninferior 90-day surgical-site infection - Related sources: R01 ### N13 · What are the follow-up, missingness and ascertainment limits within the original infection period? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original primary endpoint period is 90 days, and the SSI analysis denominators are 95/98. - Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. These denominators alone do not certify complete follow-up of all randomized participants, capture of infections at outside healthcare facilities or absence of missing information. - Reason for missing information: These denominators alone do not certify complete follow-up of all randomized participants, capture of infections at outside healthcare facilities or absence of missing information. - Required materials and conditions: 90-day follow-up, visits, administrative/clinical ascertainment, missingness and denominators - Materials to obtain first: These denominators alone do not certify complete follow-up of all randomized participants, capture of infections at outside healthcare facilities or absence of missing information. - Further research: Obtain the original follow-up, infection ascertainment, missingness, denominators and handling of events outside the study center. - Conditions for verification: 90-day follow-up, visits, administrative/clinical ascertainment, missingness and denominators - Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits - Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Noninferior 90-day surgical-site infection - Related sources: R01 ### N14 · Is antibiotic duration the same outcome as SSI? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: In the same trial, antibiotic duration was 1 day (IQR1~1) versus 8 days (IQR7~10), with the original reduction of 7 days and 87.5%. - Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Reduced duration is not combined with SSI reduction, direct resistance reduction or safety as the same effect. Details of exposure-analysis denominators and hierarchy remain unread. - Reason for missing information: Reduced duration is not combined with SSI reduction, direct resistance reduction or safety as the same effect. Details of exposure-analysis denominators and hierarchy remain unread. - Required materials and conditions: Distinguishing exposure duration, endpoint, summary statistics and denominators - Materials to obtain first: Reduced duration is not combined with SSI reduction, direct resistance reduction or safety as the same effect. Details of exposure-analysis denominators and hierarchy remain unread. - Further research: Share the exposure outcome with the related question while linking it separately from the direct infection outcome. - Conditions for verification: Distinguishing exposure duration, endpoint, summary statistics and denominators - Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits - Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Noninferior 90-day surgical-site infection - Related sources: R01 ### N15 · Are clinical importance and original small-study limitations preserved without new assessment? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The parent record describes objective 90-day SSI and a prespecified margin as strengths, and noninferiority, small size and exclusion of canceled surgery as limitations, preserving C56. - Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Unrecorded precision, the original parent verdict and axes are not repurposed as a new or subclaim score. No new sample-size, power or MCID calculations are made. - Reason for missing information: Unrecorded precision, the original parent verdict and axes are not repurposed as a new or subclaim score. No new sample-size, power or MCID calculations are made. - Required materials and conditions: Infection, margin, precision, sample size and original limitations - Materials to obtain first: Unrecorded precision, the original parent verdict and axes are not repurposed as a new or subclaim score. No new sample-size, power or MCID calculations are made. - Further research: Obtain the original sample-size assumptions, clinical margin rationale and precision information. - Conditions for verification: Infection, margin, precision, sample size and original limitations - Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits - Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Noninferior 90-day surgical-site infection - Related sources: R01 ### N16 · Are the two subclaims from the same trial kept separate from independent replications? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: One PAPRAC report records both 90-day SSI and antibiotic duration, so the two subclaim tables share the same trial and population. - Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Report entries, two questions, outcomes and time points are not added as new independent trials or participants. Final independent-study and total-participant counts remain unrecorded. - Reason for missing information: Report entries, two questions, outcomes and time points are not added as new independent trials or participants. Final independent-study and total-participant counts remain unrecorded. - Required materials and conditions: Relationships among report, trial, shared participants, outcomes and related questions - Materials to obtain first: Report entries, two questions, outcomes and time points are not added as new independent trials or participants. Final independent-study and total-participant counts remain unrecorded. - Further research: Link additional reports while preserving original identifiers and population and time-point relationships. - Conditions for verification: Relationships among report, trial, shared participants, outcomes and related questions - Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits - Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Noninferior 90-day surgical-site infection - Related sources: R01 ### N17 · What is known about company and institutional funding, in-kind support, affiliations and analysis roles? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original summary records no reported external grant or company in-kind support, and sponsorship and conduct by Insel Gruppe AG and University Hospital Bern. - Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. No reported support is not converted into certification of no support or company involvement. Separate details of employee authors, external analysis, design and writing roles remain unread. - Reason for missing information: No reported support is not converted into certification of no support or company involvement. Separate details of employee authors, external analysis, design and writing roles remain unread. - Required materials and conditions: Cash, products/in-kind support, author affiliations, external analysis and study roles - Materials to obtain first: No reported support is not converted into certification of no support or company involvement. Separate details of employee authors, external analysis, design and writing roles remain unread. - Further research: Obtain the original support, in-kind, affiliation, analysis, design and writing disclosures separately. - Conditions for verification: Cash, products/in-kind support, author affiliations, external analysis and study roles - Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits - Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Noninferior 90-day surgical-site infection - Related sources: R01 ### N18 · Are 90-day mortality counts, denominators and P distinguished from SSI? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original safety record gives 90-day all-cause mortality as 6/95 (6.3%) versus 5/98 (5.1%), P=.96. - Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. These results are not converted into antibiotic-related mortality, survival noninferiority or absence of rare harms. CI, causes, relatedness and hierarchy for the original mortality outcome remain unread, with no new calculation. - Reason for missing information: These results are not converted into antibiotic-related mortality, survival noninferiority or absence of rare harms. CI, causes, relatedness and hierarchy for the original mortality outcome remain unread, with no new calculation. - Required materials and conditions: Mortality definition, duration, arm-specific denominators, original events and testing - Materials to obtain first: These results are not converted into antibiotic-related mortality, survival noninferiority or absence of rare harms. CI, causes, relatedness and hierarchy for the original mortality outcome remain unread, with no new calculation. - Further research: Obtain original mortality, relatedness, denominator, plan, CI and follow-up materials. - Conditions for verification: Mortality definition, duration, arm-specific denominators, original events and testing - Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits - Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Noninferior 90-day surgical-site infection - Related sources: R01 ### N19 · What do the infection-resolution statement and treatment and safety collection cover? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original safety record states that all infections resolved with appropriate treatment. - Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. This statement is not extended to mean no infections, systematic collection of all harms or no risk. Details of other infections, treatments, people/events and recovery timing remain unread. - Reason for missing information: This statement is not extended to mean no infections, systematic collection of all harms or no risk. Details of other infections, treatments, people/events and recovery timing remain unread. - Required materials and conditions: Infection types, treatment exposure, follow-up, recovery, relatedness and denominators - Materials to obtain first: This statement is not extended to mean no infections, systematic collection of all harms or no risk. Details of other infections, treatments, people/events and recovery timing remain unread. - Further research: Obtain original infection, treatment-exposure, treatment-success definition, follow-up, relatedness and denominator records. - Conditions for verification: Infection types, treatment exposure, follow-up, recovery, relatedness and denominators - Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits - Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Noninferior 90-day surgical-site infection - Related sources: R01 ### N20 · Does shorter antibiotic exposure directly demonstrate reduced harms? Verification status: Unverified Reading scope: Summary read; external materials not read - Current findings: The original materials record shorter prophylactic antibiotic exposure, 90-day SSI and mortality; parent safety is Caution. - Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Shorter exposure alone does not newly establish reductions in adverse drug reactions, kidney injury, allergy or other harms. The summary lacks the relevant original outcomes, denominators and collection details. - Reason for missing information: Shorter exposure alone does not newly establish reductions in adverse drug reactions, kidney injury, allergy or other harms. The summary lacks the relevant original outcomes, denominators and collection details. - Required materials and conditions: Drug harms, collection, exposure, arm-specific events and denominators - Materials to obtain first: Shorter exposure alone does not newly establish reductions in adverse drug reactions, kidney injury, allergy or other harms. The summary lacks the relevant original outcomes, denominators and collection details. - Further research: Obtain original harm-collection records, arm-specific events/people, exposure, discontinuation, relatedness and duration. - Conditions for verification: Drug harms, collection, exposure, arm-specific events and denominators - Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits - Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Noninferior 90-day surgical-site infection - Related sources: R01 ### N21 · Are resistance selection pressure, individual resistance, costs and other infections distinguished? Verification status: Unverified Reading scope: Summary read; external materials not read - Current findings: The original review summary records both a possible reduction in resistance selection pressure and costs through less exposure, and the limitation that individual resistance emergence and costs were not directly tested. - Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Mechanistic or stewardship advantages are not converted into established direct reductions in resistance or costs or prevention of other infections. - Reason for missing information: Mechanistic or stewardship advantages are not converted into established direct reductions in resistance or costs or prevention of other infections. - Required materials and conditions: Direct outcomes, definitions and denominators for resistance, costs and infection types - Materials to obtain first: Mechanistic or stewardship advantages are not converted into established direct reductions in resistance or costs or prevention of other infections. - Further research: Obtain prespecified direct measurements, denominators, effects and follow-up for resistance, costs and other infections. - Conditions for verification: Direct outcomes, definitions and denominators for resistance, costs and infection types - Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits - Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Noninferior 90-day surgical-site infection - Related sources: R01 ### N22 · What application gaps remain for populations, surgery, drugs and resistance environments outside the single center? Verification status: Unverified Reading scope: Summary read; external materials not read - Current findings: The parent counterview records that results cannot be directly applied to robotic surgery, other antibiotic combinations or different resistance environments. - Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. No individual antibiotic choice, duration, postoperative-care or treatment-substitution guidance is generated. Efficacy and safety outside the original study conditions are not newly certified. - Reason for missing information: No individual antibiotic choice, duration, postoperative-care or treatment-substitution guidance is generated. Efficacy and safety outside the original study conditions are not newly certified. - Required materials and conditions: Direct comparisons in new populations, surgeries, drug combinations and settings - Materials to obtain first: No individual antibiotic choice, duration, postoperative-care or treatment-substitution guidance is generated. Efficacy and safety outside the original study conditions are not newly certified. - Further research: Obtain direct effects/harms, denominators and follow-up for each new population, surgery, drug and setting. - Conditions for verification: Direct comparisons in new populations, surgeries, drug combinations and settings - Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits - Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Noninferior 90-day surgical-site infection - Related sources: R01 ### N23 · Do gaps remain in durability beyond 90 days and independent replication? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The currently designated preserved summary contains one PAPRAC report and 90-day SSI. - Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Duration, outcomes and related tables are not counted as replication trials or extended to long-term resistance, readmission, mortality or all infections. - Reason for missing information: Duration, outcomes and related tables are not counted as replication trials or extended to long-term resistance, readmission, mortality or all infections. - Required materials and conditions: Long-term follow-up, new trials, populations, centers and independence relationships - Materials to obtain first: Duration, outcomes and related tables are not counted as replication trials or extended to long-term resistance, readmission, mortality or all infections. - Further research: Obtain long-term direct outcomes, independent-report relationships and center-specific materials. - Conditions for verification: Long-term follow-up, new trials, populations, centers and independence relationships - Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits - Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Noninferior 90-day surgical-site infection - Related sources: R01 ### N24 · Are the preserved summary and external abstract, full text, registration and plans distinguished? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The complete parent-verdict summary was read for production, linking the existing PubMed URL for Thurnheer et al. 2024, PMID39422911 and identifier NCT03305627. - Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. External abstract, full text, registration, protocol and SAP remain unread; no separate link test was performed. No new URL or DOI is constructed from identifiers. - Reason for missing information: External abstract, full text, registration, protocol and SAP remain unread; no separate link test was performed. No new URL or DOI is constructed from identifiers. - Required materials and conditions: Bibliography, existing links, registration identifiers and material-specific access status - Materials to obtain first: External abstract, full text, registration, protocol and SAP remain unread; no separate link test was performed. No new URL or DOI is constructed from identifiers. - Further research: Link individual original materials supplied by the user separately from their actual access status. - Conditions for verification: Bibliography, existing links, registration identifiers and material-specific access status - Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits - Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Noninferior 90-day surgical-site infection - Related sources: R01 ### N25 · Are the reference date, Korean/English texts, corrections, empty values, candidate history and production state preserved? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: 2026-08-26, empty correction and deliberation values, Korean/English texts, parent C56, Caution and axes, and the subclaim C grade and note are preserved in their original form. - Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Original statements, including the sample-size wording in the parent rationale, remain historical records without new correction or reassessment. Original review-pending and production-eligibility indicators are candidate history, not current review or completion. - Reason for missing information: Original statements, including the sample-size wording in the parent rationale, remain historical records without new correction or reassessment. Original review-pending and production-eligibility indicators are candidate history, not current review or completion. - Required materials and conditions: Distinguishing the complete preserved summary, selected verdict record, parent values, original languages and history - Materials to obtain first: Original statements, including the sample-size wording in the parent rationale, remain historical records without new correction or reassessment. Original review-pending and production-eligibility indicators are candidate history, not current review or completion. - Further research: Preserve original texts before linking additional user materials or decisions as separate events. - Conditions for verification: Distinguishing the complete preserved summary, selected verdict record, parent values, original languages and history - Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits - Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety. - Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Noninferior 90-day surgical-site infection - Related sources: R01 ## Evidence and sources ### R01 Thurnheer MC, et al. JAMA Netw Open. 2024;7:e2439382. PMID: 39422911. [PubMed](https://pubmed.ncbi.nlm.nih.gov/39422911/) Materials actually read: Summary read; external materials not read Findings recorded in the summary: 8.4% versus 12.2%, risk difference −3.8%p (90% CI −11.1~3.4), margin 10%p; duration 1 versus 8 days Record level: Preserved summary; not a result of newly comparing the external original report Independent replication: The same PAPRAC report and population for 90-day SSI and prophylactic-antibiotic exposure duration; shared by the two subclaims | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | local_summary | Existing link preserved | Summary read | Summary read | Stored parent-verdict summary | | abstract | Existing link preserved | Not read | Not read | External material unread; a URL does not mean acquisition, reading or completed review | | fulltext | No separate URL in the original material | Not read | Not read | External material unread; a URL does not mean acquisition, reading or completed review | | registration | No separate URL in the original material | Not read | Not read | External material unread; a URL does not mean acquisition, reading or completed review | | protocol_sap | No separate URL in the original material | Not read | Not read | External material unread; a URL does not mean acquisition, reading or completed review | ## 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 methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed. - 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 methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed. - 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 methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed. - 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 methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed. - 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 methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed. ## What the statuses mean - Partly verified: Some information exists in the preserved review summary, with detailed original materials still unverified; no certification of 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: Existing content review pending - Met: Use only within the relevant conditions after existing content review; no automatic designation in this preparation - Not reported: Distinguish only within materials actually read; do not turn unread external materials into unreported findings - Inaccessible: Not applied during this preparation because actual access was not tested - Not applicable: Use with a reason for non-applicability based on an explicit question boundary - Conflicting data: Judge after actual material comparison; review was not performed during this preparation - Insufficient evidence for the conditions: Do not use as a clinical grade encompassing currently unread materials ## Change history 2026-10-10 · Public page/materials 1.0. The public page and data were prepared from the existing 25 items. No new clinical search, verification-status change or scoring was performed.