RECRUITING Not applicable ClinicalTrials.gov

ENVELOP: Wound Care Following Pilonidal Sinus Surgery

Sponsor: Royal College of Surgeons, Ireland • ClinicalTrials.gov ID: NCT06647290

Registry updated: 2026-09-24

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Description

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).

Interventions

Negative Pressure Wound Therapy (Device)
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 (Other)
Standard wound care

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

Conditions

Pilonidal Sinus Wound Healing

Locations

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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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