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ENVELOP: Wound Care Following Pilonidal Sinus Surgery

RecruitingNAAges 18 Years - anyAllRoyal College of Surgeons, Ireland
NCT06647290 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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
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What it tests

  • Negative Pressure Wound Therapy
  • Standard wound care
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Where

10 sites
Mayo University Hospital
Castlebar, Ireland
Beaumont Hospital
Dublin, Ireland
St James's Hospital
Dublin, Ireland
St Michael's Hospital, Dún Laoghaire
Dublin, Ireland
St Vincent's Univeristy Hospital
Dublin, Ireland
Tallaght University Hospital
Dublin, Ireland
St. Luke's Hospital
Kilkenny, Ireland
University Hospital Limerick
Limerick, Ireland

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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