Excision and Negative Pressure Wound Therapy Versus Excision and Leaving Open With Standard Wound Care for Management of Chronic Pilonidal Sinus Disease - A Randomised Controlled Trial

What this Trial Is About

Researchers are evaluating post-operative and patient-reported outcomes for people undergoing surgery for chronic pilonidal sinus disease (PSD), a persistent skin and tissue condition in the natal cleft area. This national, multicenter randomized controlled trial compares the use of negative pressure wound therapy (NPWT) after sinus tract excision to standard open wound care. The study aims to find better management strategies to improve healing time and quality of life after surgery. Participants will be randomly assigned to one of two groups: one receiving NPWT dressings applied to the wound after surgery, and the other receiving standard gauze dressings on an open wound after skin closure. The trial is single-blinded and will observe outcomes over six months following surgery, assessing wound healing and complications. Throughout the study, participants will undergo regular assessments including measurements of wound healing time, post-operative pain, complications, and quality of life using standardized questionnaires like the EQ-5D-5L and POSAS. Economic factors and recurrence rates will also be monitored. Follow-up will include evaluations at surgery day, 1 month, 3 months, and 6 months, with a total participation duration covering these key timepoints.

ENVELOP: Wound Care Following Pilonidal Sinus Surgery