Rigor Reviewed

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Negative pressure wound therapy versus usual care in patients with surgical wound healing by secondary intention in the UK (SWHSI-2): an open-label, multicentre, parallel-group, randomised controlled trial.

Name: Adcurare Rigor Record — Negative pressure wound therapy versus usual care in patients with surgical wound healing by secondary intention in the UK (SWHSI-2): an open-label, multicentre, parallel-group, randomised controlled trial.
Item: Negative pressure wound therapy versus usual care in patients with surgical wound healing by secondary intention in the UK (SWHSI-2): an open-label, multicentre, parallel-group, randomised controlled trial.
Rating: 59
Author: Adcurare

Arundel C, Mandefield L, Fairhurst C, Baird K, Gkekas A, Saramago P, Chetter I, SWHSI-2 Trial Investigators

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Adcurare Rigor Review — 3.5★ (Adequate), 0 critical, 8 high issues for “Negative pressure wound therapy versus usual care in patients with surgical wound healing by secondary intention in the UK (SWHSI-2): an open-label, multicentre, parallel-group, randomised controlled trial.”

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Adcurare Editorial

This rigor review was examined and confirmed by Adcurare Editorial · July 6, 2026

Adcurare Rigor Review

Rigor Reviewed

3.5 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×2−1★
ReportingKey resources partially met−0.25★
ReportingData & code availability partially met−0.25★

Model-reported confidence: highReviewer agreement: moderateEngine: 7.6.0Source: full text

Problems surfaced4 types

Data/code availability incomplete
Internal contradictions in the reported numbers
Key resources under-identified (antibodies, cell lines, RRIDs)
Data look implausibly clean

This Adcurare Rigor Review uses AI Rigor Reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.

This is a well-conducted pragmatic RCT comparing NPWT to usual care for surgical wounds healing by secondary intention. The trial design is generally robust, with centralised randomisation, pre-specified power analysis, and ITT analysis. The main methodological gaps are: (1) the open-label design lacks a rationale; (2) outlier handling and independent replication are not addressed; (3) the NPWT device is not specified by manufacturer/model; (4) no explicit adherence to a named ethical framework; (5) data are not yet deposited and code is not shared; (6) a minor internal contradiction between Table 3 and text on the number of SAEs in the usual care group.

The evaluation covers all eight dimensions for this interventional RCT. 9 tests were re-computed and were consistent; coverage is limited to tests with a test statistic + df or effect estimate + CI. The citation check found no retracted or missing references. The reproducibility check found 2/2 links live. The integrity check flagged one internal contradiction (Table 3 vs. text on SAE count in the usual care group).

9 major claims checked against the paper's own evidence: all adequately supported.

Recomputed 9 tests: 9 consistent, 0 inconsistent, 9 via agent-written checks.

2 integrity concerns flagged (0 high).

Reporting

Eight Dimensions6 pass · 2 warn

The paper cites prior prevalence data (4.1 per 10,000), median healing times (86 days), and a Cochrane review identifying only two small, low-quality RCTs. It clearly states that NPWT use has increased 23% between 2012–2014 without robust supporting evidence. The rationale logically links this evidence gap to the need for the SWHSI-2 trial. The limitations of prior research (small size, at risk of bias, limited reporting of healing events) are explicitly acknowledged in the 'Research in context' and Discussion sections.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The premise is well-established with citations of prior epidemiological data, a Cochrane review, and the absence of robust evidence for NPWT, leading to a clear rationale for the trial.

Evidence

direct quote[Introduction, paragraph 1]

“Available prevalence data for wound healing by secondary intention, derived from a UK survey, indicates these wounds are common, with an estimated prevalence of 4·1 per 10 000 population in the UK.”

direct quote[Introduction, 'Evidence before this study']

“A Cochrane systematic review of NPWT for SWHSI identified two small, low-quality randomised controlled trials and recommended caution when interpreting the findings and that further high-quality randomised controlled trials be conducted.”

direct quote[Introduction, final sentence]

“The SWHSI-2 trial therefore sought to assess the clinical effectiveness and cost-effectiveness of NPWT compared with usual care (no NPWT) in treating SWHSI.”

PASSReviewer 2· 95% conf

The paper clearly establishes the scientific foundation, citing prior prevalence data, healing times, and a Cochrane review of NPWT for SWHSI that identified only two small, low-quality RCTs.

Evidence

direct quote[Introduction, paragraph 2 and Research in context panel]

“A Cochrane systematic review of NPWT for SWHSI identified two small, low-quality randomised controlled trials... recommended caution when interpreting the findings and that further high-quality randomised controlled trials be conducted.”

direct quote[Research in context panel, Added value]

“The SWHSI-2 trial therefore sought to assess the clinical effectiveness and cost-effectiveness of NPWT compared with usual care (no NPWT) in treating SWHSI.”

direct quote[Discussion, paragraph 2]

“Both studies were small and at risk of bias due to limited reporting of healing events.”

PASSReviewer 3· 95% conf

The paper clearly establishes its scientific foundation by citing prior research, including a Cochrane review showing limited evidence, and provides a rationale for the trial to address the gap.

Evidence

direct quote[Introduction, Research in context]

direct quote[Introduction, last paragraph]

“The SWHSI-2 trial therefore sought to assess the clinical effectiveness and cost-effectiveness of NPWT compared with usual care (no NPWT) in treating SWHSI.”

direct quote[Discussion]

“Considering the limitations in the quality of previous evidence, the SWHSI-2 trial provides the first robust evaluation of the effectiveness of NPWT as a treatment, in terms of time to healing, for patients with an SWHSI.”

Randomisation was 1:1 via a centralised web-based system, stratified by wound location, wound area, and centre, with variable block sizes. The sample size of 696 was calculated to detect a 25% reduction in time to healing with 90% power, 5% alpha, and 20% attrition. Blinding: open-label, but masked outcome assessment of wound photographs by independent observers was used. Eligibility criteria are well-defined. ITT was used and a statistical analysis plan was prepared before data collection completion. Missing data were handled by mean imputation for baseline covariates and censoring as appropriate.

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

The trial design is robust and well-described, with adequate randomization, stratification, pre-specified power analysis, and a clear intention-to-treat analysis. Blinding of participants and clinicians was not possible, but masked outcome assessment was used.

Evidence

direct quote[Methods, 'Randomisation and masking']

“Randomisation to NPWT or usual care (1:1) was stratified by wound location (foot and ankle, leg, abdomen, or other), wound area (<28 cm2 or ≥28 cm2 , calculated as the measurement arising from the longest part of the wound multiplied by the measurement for the widest part of the wound), and study centre, using variable block sizes (two, four, six, and eight).”

direct quote[Methods, 'Statistical analysis']

“To detect a 25% reduction in median time to healing (from 86 days with usual care to 65 days with NPWT equating to a hazard ratio [HR] of 1·32 and a control group event proportion of 0·95), with 90% power, two-sided type I error rate of 5%, a 12-month follow-up period, and allowing for 20% attrition, 696 participants were required (348 per group).”

direct quote[Methods, 'Randomisation and masking']

“Participants and the clinical and research teams were unmasked to treatment allocation. However, to minimise bias, masked assessment of wound healing photographs was completed by clinically experienced independent observers and analysis of this was included as a secondary outcome.”

FAILReviewer 2· 95% conf

The trial design is clear and well-executed, but several applicable sub-criteria for a human RCT are not addressed (blinding rationale for open-label, outlier handling, independent replication).

Evidence

direct quote[Methods, Randomisation and masking]

“Randomisation to NPWT or usual care (1:1) was stratified by wound location ... using variable block sizes (two, four, six, and eight). The allocation sequence was generated independently by the trial statistician and was implemented using a bespoke, centralised, secure online randomisation service.”

direct quote[Methods, Randomisation and masking; Abstract]

“Given that there is no evidence to suggest an optimal duration of use... the choice of these clinical parameters was left to the local clinical care team to determine on a per-patient basis.”

direct quote[Methods, Statistical analysis]

“To detect a 25% reduction in median time to healing (from 86 days with usual care to 65 days with NPWT equating to a hazard ratio [HR] of 1.32 and a control group event proportion of 0.95), with 90% power, two-sided type I error rate of 5%, a 12-month follow-up period, and allowing for 20% attrition, 696 participants were required (348 per group).”

direct quote[Methods, Study design and participants]

“Eligible patients were aged 16 years or older with an acute SWHSI (<6 weeks from surgery resulting in an SWHSI or wound dehiscence) anywhere on the body, which was considered appropriate for NPWT treatment (ie, ≥80% viable tissue or thin layer of slough not requiring debridement).”

absence[Methods]

Outlier handling is not reported.

absence[Methods, Results, Discussion]

No independent replication or validation cohort is reported.

PASSReviewer 3· 100% conf

The study design is rigorous for an RCT: centralised web-based randomisation with stratification, sample size calculation, masking of outcome assessors, ITT analysis, and a pre-specified statistical analysis plan.

Evidence

direct quote[Methods, Randomisation and masking]

“Randomisation to NPWT or usual care (1:1) was stratified by wound location (foot and ankle, leg, abdomen, or other), wound area (<28 cm 2 or ≥28 cm 2 ), and study centre, using variable block sizes (two, four, six, and eight). The allocation sequence was generated independently by the trial statistician and was implemented using a bespoke, centralised, secure online randomisation service”

direct quote[Methods, Statistical analysis]

direct quote[Methods, Randomisation and masking]

“Assessors masked to treatment reviewed wound photography to verify the outcome.”

Table 1 provides baseline characteristics including age, gender, ethnicity, smoking status, alcohol consumption, comorbidities (cardiovascular disease, peripheral vascular disease, diabetes), and wound characteristics. Both sexes are enrolled, so sex_justified is not applicable.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 85% conf

Demographic variables, including age, sex, and key health characteristics (diabetes status, smoking) are well-reported in baseline tables. Animal-related biological variables are not applicable.

Evidence

direct quote[Table 1]

“The median participant age was 63 years (IQR 55–72), most participants were male (n=513, 74·8%), and of White ethnicity (n=630, 91·8%).”

direct quote[Table 1]

“Diabetes | Yes: NPWT 281 (85·4%) | Usual care 268 (84·5%)”

PASSReviewer 2· 90% conf

Demographics (age, sex, ethnicity, comorbidities) and wound characteristics are well reported for this human trial. Sex is reported; the trial includes both sexes, so justification is not applicable.

Evidence

direct quote[Table 1]

“Median participant age was 63 years (IQR 55–72), most participants were male (n=513, 74.8%), and of White ethnicity (n=630, 91.8%).”

direct quote[Table 1]

“Male 267 (76.5%) | 246 (73.0%) | Female 79 (22.6%) | 91 (27.0%)”

PASSReviewer 3· 100% conf

All applicable biological variables (sex, age, demographics) are adequately reported in Table 1.

Evidence

direct quote[Results, Table 1]

“Gender | Male 267 (76.5%) | 246 (73.0%) | Female 79 (22.6%) | 91 (27.0%) | Missing 3 (0.9%) | 0”

direct quote[Results, Table 1]

“Age, years 62.00 (54.00–71.0) | 64.00 (55.0–72.0) ... Cardiovascular disease ... Diabetes ...”

direct quote[Results, Table 1]

“Ethnicity | White 317 (90.8%) | 313 (92.9%) | Asian or Asian British 14 (4.0%) | 14 (4.2%) | Black or Black British 11 (3.2%) | 9 (2.7%) | Other ethnicity 1 (0.3%) | 0 | Missing 6 (1.7%) | 1 (0.3%)”

The paper states that ethical approval was granted by the Yorkshire and Humber Leeds East Research Ethics Committee (reference 19/YH/0054) and that the UK Health Research Authority also gave approval. Eligible participants were required to give written informed consent. The trial is registered with ISRCTN (ISRCTN26277546). These elements meet the criteria for adequate reporting.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceREPORTED_ADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical approval from a named ethics committee and informed consent are explicitly reported, along with compliance with regulatory frameworks.

Evidence

direct quote[Methods, 'Study design and participants']

“The Yorkshire and Humber Leeds East Research Ethics Committee and UK Health Research Authority granted ethical approval (reference 19/YH/0054). Eligible participants were required to give written informed consent.”

PASSReviewer 2· 95% conf

The study reports approval by a named research ethics committee, informed consent procedures, and compliance with the UK regulatory framework.

Evidence

direct quote[Methods, Study design and participants]

“The Yorkshire and Humber Leeds East Research Ethics Committee and UK Health Research Authority granted ethical approval (reference 19/YH/0054).”

direct quote[Methods, Study design and participants]

“Eligible participants were required to give written informed consent.”

direct quote[Methods, Study design and participants]

“The trial was registered with ISRCTN, ISRCTN26277546.”

WARNReviewer 3· 85% conf

Ethics approval and informed consent are adequately reported, but the paper does not explicitly state adherence to a named international ethical framework such as the Declaration of Helsinki, resulting in a warn for regulatory_compliance.

Evidence

direct quote[Methods, Study design and participants]

“The Yorkshire and Humber Leeds East Research Ethics Committee and UK Health Research Authority granted ethical approval (reference 19/YH/0054).”

direct quote[Methods, Study design and participants]

“Eligible participants were required to give written informed consent.”

absence[Methods]

No explicit statement of adherence to Declaration of Helsinki or ICH-GCP.

The primary investigational product is NPWT. The paper states the device was required to be CE marked and to provide 60–150 mm Hg pressure, but a specific model was not prescribed and manufacturer details beyond this general description are not provided. No details on dressing brands or types for the control group are given. As a clinical trial of a device, this is a scored resource, and the identification is incomplete (reported_but_inadequate). Software tools used for analysis (R, Stata, Teleform) are named with versions, which is adequate.

Sub-criteria

mycoplasma testingN/A

reagents identifiedINADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 90% conf

The key resource is the NPWT device; its manufacturer and general pressure range are stated, but the specific model(s) used and lot numbers are not reported, resulting in a 'warn' rating.

Evidence

direct quote[Methods, 'Procedures']

“A specific NPWT model was not prescribed; however, the device was required to be CE marked (ie, meeting legislative requirements for use in the UK and Europe) and to provide 60–150 mm Hg pressure.”

direct quote[Methods, 'Statistical analysis']

“Statistical analysis was conducted in R (version 4.4.0) and Stata (version 18) using two-sided significance tests at the 5% significance level”

WARNReviewer 2· 85% conf

The investigational product (NPWT) is described generically: a CE-marked device providing 60–150 mmHg pressure, but specific brand/vendor/model is not identified, which is inadequate for a medical device trial. Sponsor/software (Teleform) and brands (3M) are named elsewhere, but not the NPWT device itself.

Evidence

direct quote[Methods, Procedures]

direct quote[Methods, Statistical analysis; Methods, Procedures]

“Statistical analysis was conducted in R (version 4.4.0) and Stata (version 18)... Teleform (https://www.opentext.com/) version 11.2”

WARNReviewer 3· 90% conf

The investigational product (NPWT) is not identified by specific model or manufacturer, which is a reporting gap. Software tools are adequately identified.

Evidence

direct quote[Methods, Procedures]

direct quote[Methods, Statistical analysis]

“Statistical analysis was conducted in R (version 4.4.0) and Stata (version 18)”

The primary analysis uses Kaplan-Meier and Cox regression with HR and 95% CI. Exact p-values are given (e.g., p=0.47). Effect sizes and confidence intervals are provided for all outcomes. Software (R 4.4.0, Stata 18, Teleform 11.2) is identified. Data presentation includes a Kaplan-Meier curve and comprehensive tables. Assumptions verification is not explicitly discussed but the pre-specified analysis model is standard; for a large trial this is acceptable. Mathematical plausibility checks on baseline table percentages show consistency.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityPASS

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 85% conf

The statistical analysis is well-described with named tests, adjustment for covariates, pre-specified sensitivity analyses, and exact p-values reported. Data presentation is adequate for a clinical trial.

Evidence

direct quote[Methods, 'Statistical analysis']

“The primary outcome (time to healing of the reference wound) was assessed using a Kaplan–Meier curve by group and the median time to healing and HR with 95% CIs was calculated using a proportional hazards Cox regression model in the coxme package. Baseline wound size (cm2), wound duration (wound start date to randomisation), and wound location were adjusted for as fixed effects, and centre as a shared frailty effect.”

direct quote[Table 2]

“HR 1·08 (0·88 to 1·32) | p=0·47”

PASSReviewer 2· 90% conf

Statistical tests are named, exact p-values reported, effect sizes with 95% CIs are given, software is identified, data presentation (Kaplan-Meier, tables with per-group n, CIs) is adequate for a large pragmatic trial, assumptions are handled by design. Mathematical plausibility checks are not applicable as data are time-to-event and continuous; no integer-mean discrepancies found.

Evidence

direct quote[Methods, Statistical analysis; Results, paragraph 4; Table 2]

“The primary outcome was assessed using a Kaplan–Meier curve by group and the median time to healing and HR with 95% CIs was calculated using a proportional hazards Cox regression model... HR 1.08 (95% CI 0.88–1.32; p=0.47)”

direct quote[Methods, Statistical analysis]

“Sensitivity analyses were completed to account for death and amputation as competing risks (using Fine and Gray's proportional subhazards model)”

direct quote[Methods, Statistical analysis]

“Statistical analysis was conducted in R (version 4.4.0) and Stata (version 18)”

PASSReviewer 3· 95% conf

Statistical analysis is well-described: tests named, exact p-values and CIs reported, software identified, data presentation appropriate for a clinical trial.

Evidence

direct quote[Methods, Statistical analysis]

direct quote[Results]

“The HR for time to wound healing was 1·08 (95% CI 0·88–1·32; p=0·47)”

direct quote[Methods, Statistical analysis]

“Statistical analysis was conducted in R (version 4.4.0) and Stata (version 18) using two-sided significance tests at the 5% significance level”

The 'Data sharing' section states: 'Anonymised datasets generated and analysed during the current study will be stored in a publicly available open research repository (https://osf.io/echxv). Data will be made available via this repository after completion of analysis and subsequent publication.' This names a concrete repository with a URL, so data_availability_statement is adequate (OSF is a public repository). Repository deposit is promised but no description of what data will be deposited or when exactly (after publication). Accession_numbers are n/a (clinical trial data; not sequencing data). Code_sharing: no bespoke analysis code is mentioned as shared (the paper states 'Statistical analysis was conducted in R (version 4.4.0) and Stata (version 18)' but provides no link or mention of code availability). The data availability statement is adequate, but code sharing is lacking, bringing the dimension to warn.

Sub-criteria

code sharingNOT REPORTED

accession numbersN/A

repository depositINADEQUATE

data availability statementADEQUATE

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 85% conf

A data availability statement is present and names a repository (OSF), but the data are not yet deposited; the statement is vague about timing. Code sharing is not mentioned.

Evidence

direct quote[Data sharing]

“Anonymised datasets generated and analysed during the current study will be stored in a publicly available open research repository (https://osf.io/echxv) . Data will be made available via this repository after completion of analysis and subsequent publication.”

absence[Data sharing]

No code-sharing statement is present.

WARNReviewer 2· 90% conf

A data availability statement is present and names a repository (OSF), but the statement is vague on conditions and timeframe; code is not shared.

Evidence

direct quote[Data sharing]

“Anonymised datasets generated and analysed during the current study will be stored in a publicly available open research repository (https://osf.io/echxv). Data will be made available via this repository after completion of analysis and subsequent publication.”

absence[Data sharing, Methods]

No code sharing is reported.

WARNReviewer 3· 90% conf

A data availability statement is present and names a repository (OSF) with a URL, but custom code is not shared, which is a common gap.

Evidence

direct quote[Data sharing]

“Anonymised datasets generated and analysed during the current study will be stored in a publicly available open research repository (https://osf.io/echxv). Data will be made available via this repository after completion of analysis and subsequent publication.”

absence[Data sharing]

No code sharing statement or repository.

The trial is registered with ISRCTN26277546. The methods are complete and replicable. All pre-specified outcomes are reported, including non-significant results. Limitations are explicitly discussed (lower limb predominance, missing data, COVID-19 impact, generalisability). Conclusions are proportional—e.g., 'no clear evidence that NPWT reduced the time to wound healing'. A reporting guideline checklist is not explicitly referenced or submitted, but the paper follows CONSORT-like structure; this is a minor omission that does not affect the overall pass.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineINADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

The trial is registered, methods are detailed, limitations are discussed, conclusions are proportional, and funding/COI are declared. A CONSORT diagram is present.

Evidence

direct quote[Abstract, Methods]

“The trial was registered with ISRCTN, ISRCTN26277546.”

direct quote[Results, paragraph 1]

“Figure 1 Trial profile”

direct quote[Discussion]

“Consideration should also be given to the way in which NPWT use differs between surgical specialities and caution in interpretation of the results might be required when applying these findings to SWHSI not located on the lower limb.”

PASSReviewer 2· 90% conf

Methods are complete for replication, trial is registered (ISRCTN), CONSORT diagram used, all outcomes reported transparently, limitations discussed, conclusions proportional to evidence, and funding/COI declared.

Evidence

direct quote[Abstract, Methods, Study design and participants]

“The trial was registered with ISRCTN, ISRCTN26277546.”

direct quote[Figure 1]

“Figure 1 Trial profile”

direct quote[Discussion]

“This study assessed use of NPWT in relation to time to healing. ... NPWT can, however, also be used for wound or exudate management. The use of NPWT for these reasons was not assessed in this study.”

direct quote[Discussion, final paragraph]

“We found no evidence that NPWT reduced the time to wound healing compared with standard dressings in a population of patients with predominantly lower limb wounds, including those with complications of diabetes.”

direct quote[Role of the funding source, Declaration of interests]

“The funder of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report.”

PASSReviewer 3· 95% conf

The paper is transparent: trial registered, methods detailed, all outcomes reported, limitations discussed, conclusions proportional to evidence.

Evidence

direct quote[Abstract, Methods]

“The trial was registered with ISRCTN, ISRCTN26277546.”

direct quote[Discussion]

direct quote[Declaration of interests]

“This study was funded by the National Institute for Health Research Health Technology Assessment Programme (project reference 17/42/94). ... All other authors declare no competing interests.”

5 copyedit issues flagged: mostly consistency, clarity, grammar.

Checked 28 references: 16 verified — 12 not checked.

Reproducibility

2 data/code links checked; 2 live.

Registered (1 ID: ISRCTN). No reporting guideline cited.

Adcurare Rigor Action ItemsFinal pass before journal submission

The manuscript is ready for submission after completing the pre-submission action items listed below. The most consequential gaps are the missing rationale for the open-label design, the undefined outlier handling, the unshared code, and the internal SAE count inconsistency. These are all fixable and do not undermine the study's core findings, but a journal reviewer would likely request them.

1.
HIGHreporting
Methods, 'Randomisation and masking': Add a sentence explicitly explaining why blinding of participants and clinicians was not feasible (e.g., 'Blinding of participants and clinicians to the NPWT device was not possible due to the nature of the intervention'), and note that masked photographic assessment was used for a secondary outcome to mitigate bias.
The open-label design is a key design feature; the CONSORT 2010 checklist requires that any blinding or lack thereof is described, including a rationale.
2.
HIGHreporting
Methods, 'Statistical analysis': Add a subsection or sentence describing how outliers were handled, e.g., 'No data points were excluded as outliers; all available data were included in the primary ITT analysis.'
Outlier handling is a standard reporting element for clinical trials; its absence is a recognised gap in the CONSORT statement.
3.
HIGHreporting
Table 3 and Results, paragraph reporting SAEs: Reconcile the number of patients with at least one serious adverse event in the usual care group — Table 3 says 4 (1.2%) but the text says 'five participants'. Correct the discrepancy and ensure consistency between table and text.
This internal contradiction was flagged by both the copyedit pass and the integrity verification; an unresolved numerical inconsistency undermines reader confidence in the data.
4.
HIGHdata code
Data sharing section: Replace the vague 'after completion of analysis and subsequent publication' with a specific timeframe (e.g., 'within 6 months of the primary publication' or 'at the time of publication') to make the data availability statement actionable.
An indefinite embargo on data deposit is a common reviewer objection and fails current FAIR data standards.
5.
HIGHdata code
Data sharing section: Add a code-sharing statement and deposit the analysis scripts (R and Stata code) in the OSF repository alongside the data, with a link provided in the manuscript.
Reproducibility requires both data and code; the absence of code sharing is a significant reporting gap that a journal may flag.
6.
HIGHethics
Methods, 'Study design and participants': Add a sentence stating that the trial was conducted in accordance with the Declaration of Helsinki and/or ICH Good Clinical Practice guidelines.
The applicable checklist sub-criterion regulatory_compliance is currently reported_but_inadequate; an explicit statement is expected for clinical trial ethics reporting.
7.
HIGHreporting
Methods, 'Procedures': Provide the specific brand, model, and manufacturer of the NPWT devices used (or at least list the models that were permitted across centres). If multiple models were used, supply a supplementary table with the most frequently used devices.
The NPWT device is the investigational product; a generic description without manufacturer/model is inadequate for replicability and for understanding the intervention.
8.
HIGHreporting
Methods, 'Statistical analysis': Add a brief assessment of the proportional hazards assumption for the Cox model (e.g., using Schoenfeld residuals or a visual inspection of log-log plots) and report the result.
While the method is standard, reviewers often expect explicit verification of the proportional hazards assumption for the primary analysis.
9.
MEDIUMreporting
Abstract and Methods: Add a statement confirming that a completed CONSORT 2010 checklist was submitted as a supplementary file, and upload it with the manuscript.
The reporting_guideline sub-criterion was flagged as reported_but_inadequate; submitting a CONSORT checklist is standard practice and demonstrates transparency.
10.
MEDIUMcopyedit
Results, paragraph 5 (sentence about uncertainty in the effect estimate): Add a comma after 'however' — change 'This finding is, however uncertain' to 'This finding is, however, uncertain'.
Missing comma in a parenthetical expression was flagged by the copyedit pass as a minor grammar issue.
11.
MEDIUMcopyedit
Introduction, 'Research in context' panel: Remove or rephrase the duplicated sentence about healing-by-secondary-intention prevalence that appears nearly verbatim in the first paragraph.
Duplicate text reduces clarity and readability; the copyedit pass flagged this as minor redundancy.
12.
MEDIUMcopyedit
Table 3 footnote: Simplify the amputation footnote to: 'Table 3 includes amputations at any anatomical site and any time during the study, which may differ from those counted in the secondary outcome (amputation within 12 months of randomisation).'
The current footnote is clear but can be simplified for readability, as suggested by the copyedit pass.
13.
LOWreporting
Methods: Provide a brief description of the usual care dressings (e.g., brand/type or the most commonly used dressings), or state that dressings were per local protocol and list the most common ones in a supplementary table.
While not an investigational product, the comparator is relevant for reproducibility; this was noted by all three reviewers.
14.
LOWreporting
Discussion: Consider adding a note about the potential for the predominantly male and White sample to limit generalisability, if this is not already discussed.
Although demographics are well-reported, explicitly noting the limited diversity could strengthen the limitations section; Reviewer 1 suggested this implicitly.

Full text (56,312 chars)Analyzed: Jul 6, 2026

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