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
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• i) They are aged 18 years or older
• ii) They are undergoing elective pilonidal sinus excision without primary closure
Locations
Other Locations
Ireland
Mayo University Hospital
NOT_YET_RECRUITING
Castlebar
University Hospital Cork
NOT_YET_RECRUITING
Cork
Beaumont Hospital
NOT_YET_RECRUITING
Dublin
St Michael's Hospital Dun Laoighre
NOT_YET_RECRUITING
Dublin
Tallaght University Hospital
NOT_YET_RECRUITING
Dublin
University Hospital Galway
NOT_YET_RECRUITING
Galway
St. Luke's Hospital
NOT_YET_RECRUITING
Kilkenny
University Hospital Limerick
NOT_YET_RECRUITING
Limerick
Midlands University Hospital
NOT_YET_RECRUITING
Tullamore
University Hospital Waterford
RECRUITING
Waterford
Contact Information
Primary
Sean T Martin
seanmartin@rcsi.ie
(01) 261 4037
Backup
Eanna Ryan
eannaryan@rcsi.ie
(01) 261 4037
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2027-04-27
Participants
Target number of participants: 200
Treatments
Experimental: Negative Pressure Wound Therapy
The wound is dressed using negative pressure wound therapy.
Active_comparator: Standard Wound dressing
After the skin is closed, the wound is covered using sterile standard gauze dressing.
Related Therapeutic Areas
Sponsors
Leads: Royal College of Surgeons, Ireland