NCT06647290 ENVELOP: Wound Care Following Pilonidal Sinus Surgery
| NCT ID | NCT06647290 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Royal College of Surgeons, Ireland |
| Condition | Pilonidal Sinus |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2024-10-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 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
Contact & Investigator
Sean T Martin
PRINCIPAL INVESTIGATOR
St. James's Hospital, Ireland
Frequently Asked Questions
Who can join the NCT06647290 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pilonidal Sinus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06647290 currently recruiting?
Yes, NCT06647290 is actively recruiting participants. Contact the research team at seanmartin@rcsi.ie for enrollment information.
Where is the NCT06647290 trial being conducted?
This trial is being conducted at Dublin, Ireland, Castlebar, Ireland, Dublin, Ireland, Dublin, Ireland and 6 additional locations.
Who is sponsoring the NCT06647290 clinical trial?
NCT06647290 is sponsored by Royal College of Surgeons, Ireland. The principal investigator is Sean T Martin at St. James's Hospital, Ireland. The trial plans to enroll 200 participants.