RecruitingNot Applicable

ENVELOP: Wound Care Following Pilonidal Sinus Surgery

Ireland200 participantsStarted 2024-10-01

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time to complete wound healing

Timeframe: 6 months post surgery

Trial details

NCT IDNCT06647290

SponsorRoyal College of Surgeons, Ireland

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Sean T Martin

(01) 261 4037 seanmartin@rcsi.ie

View on ClinicalTrials.gov More Pilonidal Sinus trials