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

Abstract

Introduction: 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. Methods: 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. Results: 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. Conclusion: 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. Trial Registration: NCT04985552.