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Recruiting
NCT06647290
ENVELOP: Wound Care Following Pilonidal Sinus Surgery
Conditions: Pilonidal Sinus, Wound Healing
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 200
Sponsor: Royal College of Surgeons, Ireland
Location: Mayo University Hospital Castlebar
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 Criteria
Inclusion Criteria:
i) They are aged 18 years or older
ii) They are undergoing elective pilonidal sinus excision without primary closure
Exclusion Criteria:
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 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
Source: ClinicalTrials.gov (NCT06647290). StuddyBuddy aggregates publicly available trial information.