Necrotising infection and Fournier's gangrene

• Novel 3-step "eso-endo" NPWT technique: two sponges bridged through the rectal fistula so suction runs cavity-to-rectum, promoting depth-to-surface granulation and preventing fistula enlargement.
• Case managed with early debridement, diverting blow-out colostomy, culture-directed antibiotics (Meropenem/Tigecycline/Fluconazole; Enterococcus raffinosus, Proteus mirabilis), NPWT for 32 days and concurrent HBOT; bilateral perineal wounds closed primarily, no residual rectal defect.
• Review consensus: WSES/SIS-E recommend NPWT after complete necrotic-tissue removal, but the authors state clinical evidence of NPWT's added benefit over conventional dressing is not yet proven.
• Reported NPWT advantages across included studies: fewer dressing changes, less pain, greater mobility, reduced tissue exudate/edema, and support for skin-graft/dermal-matrix take.
• Iacovelli et al. cohort (n=92) cited: NPWT gave faster healing at 10 weeks and higher 90-day survival in disseminated (not local) FG; some studies (e.g. Yucel) found longer stay/more debridements with NPWT reflecting worse baseline disease.

CAT: OCEBM 4 · There is no effect estimate in this paper. Twenty-eight articles were included — 21 case reports or series and 7 cohorts — and the authors state that meta-analysis was not possible because of clinical and methodological heterogeneity. GRADE therefore begins Low for a body of uncontrolled observational evidence and falls to Very low for risk of bias and imprecision, and it attaches to a description of practice, not to a treatment effect. The review's own verdict is the citable finding: 'the heterogeneity and the low quality of evidence of all of the included studies do not lead to reliable conclusions', and separately that although WSES and SIS-E recommend NPWT after complete necrotic-tissue removal, clinical evidence of its added benefit over conventional dressing is not proven. The review also contains direct evidence against NPWT that the abstract does not carry. Yucel 2017 (n = 25) found NPWT associated with LONGER hospital stay and MORE debridements, which the authors attribute to worse baseline disease rather than to the dressing. Gul 2021 (22 cases, NPWT in 12) found no statistically significant benefit for mortality or morbidity. Ozturk 2009 (n = 10, five per arm) found no difference in length of stay or time to therapy. The one supportive cohort is Iacovelli 2021 (n = 92), which reported faster healing at 10 weeks and higher 90-day survival in disseminated but not in local Fournier's — and which also reported LONGER length of stay in the NPWT arm in both groups. The case itself is confounded: hyperbaric oxygen was co-administered alongside 32 days of NPWT at minus 125 mmHg continuous, so the contribution of NPWT cannot be isolated, and the authors say as much.

Figures: Figures checked

Overall mortality 19 of 95 (20.0%). Independent prognostic factors: FGSI per point OR 1.28 (1.10–1.55), procalcitonin per ng/mL OR 1.95 (1.35–2.75); qSOFA ≥ 2 OR 2.85 (1.40–5.80) in the sensitivity model. AUC: FGSI 0.82, qSOFA 0.78, procalcitonin 0.80.

"Patients in the conventional group had higher FGSI and procalcitonin levels and were older, indicating more severe disease at baseline. Although adjusted analysis showed that NPWT/VAC was independently associated with lower mortality, residual confounding cannot be excluded."

CAT: OCEBM 4 (retrospective cohort, non-randomised allocation). GRADE Very low for any mortality effect of NPWT: starts Low, downgraded for risk of bias (confounding by indication acknowledged, allocation by surgeon) and imprecision (19 events; crude p = 0.17 on recomputation). ROBINS-I: critical (confounding) · Start low for a non-randomised comparison. Downgrade for risk of bias: the exposure was assigned 'at the discretion of the treating surgeon based on clinical judgment, wound characteristics, and device availability, without predefined criteria', and the group that did not get NPWT was older (65.3 vs 59.9), sicker (FGSI 7.6 vs 6.4) and more inflamed (procalcitonin 8.9 vs 6.3), each printed as p < 0.05 in Table 1 — confounding by indication in the direction that produces the result, stated by the authors themselves in the Discussion. Downgrade for imprecision: 19 deaths in total; the crude contrast 29.0% vs 15.6% is printed as p < 0.05 but recomputes to Fisher two-tailed p = 0.17 (chi-squared without correction 0.13, with Yates 0.21); the adjusted OR 0.42 (0.18–0.95) comes from a five-covariate model on 19 events, below four events per variable, where confidence intervals are unreliable in principle; and the paper's power statement — 74% for 30 per group at 29% vs 15.6% — recomputes to about 24%, with roughly 150 per group needed for 80%. Very low. What survives: the cohort's overall mortality, 20% (19 of 95), is in the range every Fournier's series reports, and the prognostic findings — FGSI per point OR 1.28 (1.10–1.55), procalcitonin per ng/mL OR 1.95 (1.35–2.75), qSOFA ≥ 2 OR 2.85 (1.40–5.80), all with AUCs near 0.8 — are consistent with the literature and are the usable content. The paper's own last sentence, that the effect on survival 'remains uncertain', is the grade in words. It sits beside Küçük 2026 (268 patients, same country, same design, same flaw) and Iacovelli 2020, and adds a third cohort in which NPWT is given to the patients most likely to survive.

Figures: Figures checked

% wound-area reduction, median (IQR), as stated in the abstract and text (the table headers are reversed):

• Pain: no difference at any time point.
• Positive cultures: 22/24 in each arm at baseline. After 2 weeks: 5/24 with HBOT vs 6/24 without; no difference.
• Population: 18/24 per arm necrotising fasciitis; diabetes 7/24 (NPWT alone) vs 6/24 (NPWT + HBOT).

CAT: GRADE very low (HBOT added to NPWT; surrogate area-reduction outcome) · Start high (RCT). −1 risk of bias: unblinded patients and treating teams, retrospective registration, mislabelled result tables, per-timepoint testing without a repeated-measures model, two losses per arm by day 12. −1 indirectness: % area reduction over 12 days is a surrogate; 'chronic' wounds were mostly debrided necrotising fasciitis; anticoagulant and antiplatelet users excluded, which removes most vascular patients. −1 imprecision: 48 patients. Very low.

Figures: Figures checked