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ENVELOP: Wound Care Following Pilonidal Sinus Surgery
Sponsor: Royal College of Surgeons, Ireland
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).
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2024-10-01
Completion Date
2027-06
Last Updated
2026-09-24
Healthy Volunteers
No
Conditions
Interventions
Negative Pressure Wound Therapy
Following elective excision of chronic pilonidal sinus disease with the wound left open, NPWT is applied in theatre using a polyurethane foam-based system (e.g. VAC, Renasys-GO, Prevena or equivalent) cut to fit the wound cavity, sealed with an adhesive drape and connected to a portable pump at -125 mmHg continuous pressure. Dressings are changed every 48-72 hours in clinic until granulation reaches skin level, followed by standard dressings until epithelialisation.
Standard wound care
Standard wound care
Locations (10)
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
Midlands University Hospital
Tullamore, Ireland
University Hospital Waterford
Waterford, Ireland