ENVELOP: Wound Care Following Pilonidal Sinus Surgery
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
Royal College of Surgeons, Ireland
200 participants
Oct 1, 2024
INTERVENTIONAL
Summary
This is a single-blinded, multicentre, prospective randomised controlled trial (RCT) comparing post-operative and patient-reported outcomes for patients undergoing application of negative-pressure wound therapy (NPWT) after sinus tract excision as compared to excision and standard open wound care in chronic pilonidal sinus disease (PSD).
Eligibility
Inclusion Criteria2
- i) They are aged 18 years or older
- ii) They are undergoing elective pilonidal sinus excision without primary closure
Exclusion Criteria5
- i) They are unable to adhere to protocol requirements e.g. questionnaire completion
- ii) They are undergoing emergency drainage for a pilonidal abscess
- iii) They are undergoing surgery for a pilonidal sinus disease in locations other than the natal cleft
- iv) They have underlying osteomyelitis
- v) They have underlying fistulating disease e.g. Crohn's
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Interventions
Application of a negative wound pressure therapy dressing to the wound post laparotomy
Locations(10)
View Full Details on ClinicalTrials.gov
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NCT06647290