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
- Pilonidal Sinus
- Wound Healing
At a glance
- Phase
- Phase not stated
- Study type
- Interventional
- Sponsor
- Royal College of Surgeons, Ireland
- Enrolment target
- 200
- Started
- 1 October 2024
- Main results due
- December 2026
- Study sites
- 10
- Registry updated
- 24 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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
What this study is about
In the sponsor’s own words, from the registry.
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).
Study sites(10)
Mayo University Hospital
Castlebar, Ireland
Recruiting
Beaumont Hospital
Dublin, Ireland
Recruiting
St James's Hospital
Dublin, Ireland
Recruiting
St Michael's Hospital, Dún Laoghaire
Dublin, Ireland
Recruiting
St Vincent's Univeristy 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
Showing 10 of 10 sites. 10 of the 10 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06647290. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
Not the right study?
Answer three questions and see the studies recruiting near you, in plain language.
Find a study for me