ENVELOP: Wound Care Following Pilonidal Sinus Surgery

NCT06647290 · tracked via the Priya Life Science Ireland tracker

Sponsor

Royal College of Surgeons, Ireland

Phase

Not applicable

Started

2024-10-01

Last updated

2026-07-22

Condition(s) studied

Pilonidal SinusWound Healing

Investigational drug(s) / intervention(s)

Negative Pressure Wound Therapy

Negative Pressure Wound Therapy: Application of a negative wound pressure therapy dressing to the wound post laparotomy

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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 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

Primary outcome measure(s)

Time to complete wound healing — 6 months post surgery
Number of days to complete epithelialisation or closure of the wound without any discharge, drainage, scab, and/or the requirement for further dressing. The quality of wound healing will be assessed using a validated patient and observer reported scar assessment tool-POSAS.

Trial sites (10)

Facility	City	Region	Status
Beaumont Hospital	Dublin	Dublin	Recruiting
Mayo University Hospital	Castlebar	Ireland	Recruiting
St James's Hospital	Dublin	Ireland	Recruiting
St Michael's Hospital Dun Laoighre	Dublin	Ireland	Recruiting
St Vincent's Hospital	Dublin	Ireland	Recruiting
Tallaght University Hospital	Dublin	Ireland	Recruiting
St. Luke's Hospital	Kilkenny	Ireland	Recruiting
University Hospital Limerick	Limerick	Ireland	Recruiting
Midlands University Hospital	Tullamore	Ireland	Recruiting
University Hospital Waterford	Waterford	Ireland	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06647290 on ClinicalTrials.gov ↗ ← All trials in Ireland