Single-blinded, randomized study comparing healing after Bascom's cleft lift operation for pilonidal disease with or without negative wound pressure management

Aim: Despite the favorable outcomes of off‐midline closure techniques in pilonidal surgery in terms of recurrence, between 18% and 40% of operated patients suffer prolonged postoperative wound healing. We aimed to investigate whether negative wound pressure therapy (NWPT) (Prevena™ Customizable Dressing connected to ACTIV.A.C™ Therapy System) after Bascoms Cleft Lift (BCL) surgery for pilonidal disease would improve wound healing compared to a control group of patients treated with conventional drainage and dressing. Methods: In a single blinded, controlled randomized setting we aimed to include 200 patients with pilonidal disease undergoing BCL surgery. Patients were randomized to receive BCL surgery either with or without NWPT treatment for 4‐7 days post‐operatively or Penrose drain for 24 h and a dry dressing. Healing was evaluated by a blinded nurse 14 days postoperatively (primary endpoint) and considered healed if ≤1 closing defect of ≤5 mm and no undermining of the cicatrices was present. Results: Interim analysis was done after the inclusion of 109 patients (NWPT group, n = 53; control). Patients were comparable by age (p = 0.59), gender distribution (p = 0.29), BMI (p = 0.95), smoking status (p = 0.45) and indication (primary extensive, recurrence after elective surgery or non‐healing wounds after surgery; p = 0.8). By our definition only 14.6% patients were healed at 14 days postoperatively in the NWPT group compared to 12.5% in the control group (p = 0.39). At 30 days postoperatively 58.2% of patients were healed in the NWPT group vs. 66.1% in the control group (p = 0.32). Conclusion: Negative wound pressure therapy does not seem to facilitate healing after BCL surgery for pilonidal disease where wound healing is a very common problem. The study has been stopped as we do not expect results to differ with increased numbers.