Closed-Incision Negative Pressure Therapy Compared to Conventional Dressing Following Autologous Abdominal Tissue Breast Reconstruction: The MACVAC Pilot Randomized Control Trial.

The pilot study suggests that closed-incision negative pressure therapy may reduce wound dehiscence rates compared to conventional dressings, but further research is needed to confirm these results.

Summary and findings

This pilot randomized controlled trial compared closed-incision negative pressure therapy (ciNPT) to conventional dressings following abdominal tissue breast reconstruction in adult female patients. The study aimed to assess the feasibility of conducting a larger trial, reporting various recruitment and retention rates. Wound dehiscence rates were observed at 16.7% for ciNPT and 41.7% for conventional dressings.

Abstract

<b>Introduction:</b> There is equipoise regarding the use of closed-incision negative pressure therapy (ciNPT) versus conventional dressings for abdominal incisions in deep inferior epigastric perforator (DIEP) flap breast reconstruction. The primary objective was to determine the feasibility of conducting a randomized controlled trial (RCT) comparing ciNPT versus conventional dressings for abdominal incisions in DIEP flap breast reconstruction. <b>Methods:</b> A parallel, between-group randomized controlled pilot trial was conducted at two academic breast reconstruction centers. Participants were included if they were adult female patients (≥18 years old) receiving immediate or delayed DIEP flap breast reconstruction. Participants were excluded if they were pregnant, had an allergy to adhesive dressings, or had a body mass index ≥40 kg/m². Primary feasibility outcomes were attaining a 90% eligibility rate, 85% recruitment rate, and 85% retention rate. Secondary outcomes were abdominal site complications and patient-reported health-related quality of life measurements. Block randomization was performed in a 1:1 ratio intraoperatively following abdominal incision closure. Outcome assessment was performed by a blinded assessor. <b>Results:</b> There were 12 patients randomized to each group. The eligibility rate was 90.6%, recruitment rate was 86.2%, pre-randomization retention rate was 96.0%, and post-randomization retention rate was 95.8%. Wound dehiscence rates were 16.7% in the intervention and 41.7% in the control group. <b>Conclusion:</b> The full RCT was deemed feasible based on a priori feasibility outcomes. The anticipated sample size will be 54 patients per group to achieve adequate statistical power. The full multicenter trial is currently in the recruitment process.

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