Closed-Incision Negative Pressure Therapy Compared to Conventional Dressing Following Autologous Abdominal Tissue...

Area of Science:

• Plastic Surgery
• Surgical Innovation
• Clinical Trial Methodology

Background:

• Equipoise exists regarding the optimal dressing for abdominal incisions in deep inferior epigastric perforator (DIEP) flap breast reconstruction.
• Closed-incision negative pressure therapy (ciNPT) is a potential alternative to conventional dressings, but its efficacy in this specific context requires investigation.
• A pilot study is crucial to assess the feasibility of a larger randomized controlled trial (RCT).

Purpose of the Study:

• To determine the feasibility of conducting a randomized controlled trial (RCT) comparing ciNPT versus conventional dressings for abdominal incisions in DIEP flap breast reconstruction.
• To evaluate primary feasibility outcomes including eligibility, recruitment, and retention rates.
• To explore secondary outcomes such as abdominal site complications and patient-reported quality of life.

Main Methods:

• A parallel, between-group randomized controlled pilot trial conducted at two academic breast reconstruction centers.
• Inclusion criteria: adult female patients undergoing DIEP flap breast reconstruction; exclusion criteria: pregnancy, adhesive allergy, BMI ≥40 kg/m².
• Block randomization (1:1) intraoperatively, with outcome assessment by a blinded assessor.

Main Results:

• Feasibility targets were met: eligibility (90.6%), recruitment (86.2%), and retention (95.8% post-randomization).
• Wound dehiscence rates were significantly lower in the ciNPT group (16.7%) compared to the conventional dressing group (41.7%).
• 12 patients were randomized to each group.

Conclusions:

• The full RCT comparing ciNPT to conventional dressings for DIEP flap abdominal incisions is feasible based on the pilot study's outcomes.
• An anticipated sample size of 54 patients per group is required for adequate statistical power in the full trial.
• The full multicenter trial is currently recruiting patients.