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Preoperative Surgical-Field Antisepsis with a pH-Optimized Sodium Hypochlorite Wound Cleanser in Microsurgical Diabetic Foot Reconstruction: A Single-Center Feasibility Study
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DOI：10.3390/jcm15166272.png)
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Abstract
En 中文
Background/Objectives: Postoperative infection is the leading cause of limb loss after microsurgical reconstruction of diabetic foot ulcers (DFUs), and povidone-iodine alone neither disrupts wound-bed biofilm nor penetrates hyperkeratotic debris. We assessed the feasibility of whole-field preoperative antisepsis with a pH-optimized sodium hypochlorite (NaOCl) cleanser applied before povidone-iodine draping. Methods: Consecutive patients undergoing microsurgical DFU reconstruction (January 2023–May 2024) were grouped by date of protocol introduction into pre-protocol (n = 9) and post-protocol (n = 6) cohorts. Primary outcome: technical feasibility, assessed by protocol completion, operative time, flap survival, limb salvage, and flap revision. Secondary, descriptive: postoperative infection, early (≤30 days) or late (>30 days). Results: The protocol was delivered as specified in all six post-protocol patients, without procedural modification or attributable adverse event. Operative time did not differ (388 vs. 430 min; p = 0.596); flap survival and limb salvage were 100% in both groups, with one flap revision per group. Baseline characteristics were comparable. Early infection was similar (16.7% vs. 11.1%; p = 1.000); late infection was absent post-protocol versus 33.3% pre-protocol (OR 0.14, 95% CI 0.01–3.4); and total infection was 16.7% versus 44.4% (OR 0.33, 95% CI 0.04–3.0). Follow-up was asymmetric (4.5 vs. 24.5 months); a 6-month landmark analysis showed 0 of 3 versus 3 of 6 (p = 0.464). Conclusions: Whole-field preoperative NaOCl antisepsis was technically feasible, with no adverse effect on flap survival or limb salvage. No statistically significant differences in the parameters were detected, though the sample is too small to establish comparability. An adequately powered trial is required.
Keywords:
diabetic foot ulcer
microsurgical reconstruction
sodium hypochlorite
biofilm
surgical site infection
feasibility study
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