RecruitingNot ApplicableNCT06647290

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


Sponsor

Royal College of Surgeons, Ireland

Enrollment

200 participants

Start Date

Oct 1, 2024

Study Type

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

Min Age: 18 Years

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

DEVICENegative Pressure Wound Therapy

Application of a negative wound pressure therapy dressing to the wound post laparotomy


Locations(10)

Mayo University Hospital

Castlebar, Ireland

University Hospital Cork

Cork, Ireland

Beaumont Hospital

Dublin, Ireland

St Michael's Hospital Dun Laoighre

Dublin, Ireland

Tallaght University Hospital

Dublin, Ireland

University Hospital Galway

Galway, Ireland

St. Luke's Hospital

Kilkenny, Ireland

University Hospital Limerick

Limerick, Ireland

Midlands University Hospital

Tullamore, Ireland

University Hospital Waterford

Waterford, Ireland

View Full Details on ClinicalTrials.gov

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NCT06647290