Comparing Negative Pressure Wound Therapy to Standard Open Wound Care After Pilonidal Sinus Surgery in Adults

What this Trial Is About

Researchers are evaluating the effects of negative pressure wound therapy NPWT compared to standard open wound care after surgical excision in patients with chronic pilonidal sinus disease PSD. PSD is a chronic inflammatory skin condition in the natal cleft area, often causing infection, abscess, discharge, and pain. The condition affects many, especially young adult males, and has a significant impact on quality of life and healthcare due to frequent recurrence and readmission after surgery. This multicenter randomized controlled trial aims to find the best wound care method to improve healing and patient outcomes. Participants will undergo surgical excision of chronic PSD and be randomly assigned to one of two groups. One group will receive negative pressure wound therapy dressings applied to the wound post-surgery, while the other group will have their wound dressed with standard sterile gauze after the skin is closed. The study will compare these two approaches for up to six months post-surgery, monitoring healing times and other related outcomes. During the study, participants will be followed for six months after surgery. Researchers will assess time to complete wound healing, postoperative pain, complications, quality of life using questionnaires like the EQ-5D-5L, scar appearance using the Patient and Observer Scar Assessment Scale POSAS, costs to patients, and wound recurrence rates. These assessments will occur at various points including the day of surgery, and one, three, and six months afterward, helping to understand the impact of each wound care method on recovery and patient experience.

ENVELOP: Wound Care Following Pilonidal Sinus Surgery