Wound care after pilonidal sinus surgery
Official title: 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
Run by Royal College of Surgeons, Ireland · NCT06647290 · Data updated 2026-11-12
This study tests if a special wound treatment helps people heal better and feel happier after surgery for pilonidal sinus disease compared to regular wound care.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Royal College of Surgeons, Ireland Academic / other |
| Locations | 10 sites (Castlebar and 9 other locations) |
| Status | Recruiting |
| Started | October 1, 2024 |
| Main results expected | December 2026 |
| Study ends | June 2027 |
| Registry record updated | September 24, 2026 |
| Trial ID | NCT06647290 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 years or older who are scheduled for elective excision of pilonidal sinus without primary closure.
✕Probably not a fit
Patients who may not benefit from this study include those undergoing emergency drainage for a pilonidal abscess or those with underlying conditions like osteomyelitis or Crohn's disease.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of negative pressure wound therapy (NPWT) compared to standard open wound care following surgical excision of chronic pilonidal sinus disease (PSD). It is a single-blinded, multicentre, prospective randomized controlled trial that aims to evaluate post-operative and patient-reported outcomes. The study focuses on optimizing wound healing time and improving patient quality of life after surgery for this common condition. Participants will be monitored for their recovery and satisfaction with the treatment received.
Why it matters
Potential benefit: If successful, this study could lead to improved wound healing and reduced complications for patients undergoing surgery for pilonidal sinus disease.
How similar studies have gone: Other studies have shown promising results with negative pressure wound therapy in various surgical contexts, suggesting potential success for this approach in pilonidal sinus surgery.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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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
Show 4 more locations
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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
Study contacts
- Principal investigator: Sean T Martin — St. James's Hospital, Ireland
- Study coordinator: Sean T Martin
- Email: seanmartin@rcsi.ie
- Phone: (01) 261 4037
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.