Wound care after 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

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

• Phase: NA
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Royal College of Surgeons, Ireland (other)
• Locations: 10 sites (Castlebar and 9 other locations)
• Trial ID: NCT06647290 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

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

Where this trial is running

Castlebar and 9 other locations

• Mayo University Hospital — Castlebar, Ireland (NOT_YET_RECRUITING)
• University Hospital Cork — Cork, Ireland (NOT_YET_RECRUITING)
• Beaumont Hospital — Dublin, Ireland (NOT_YET_RECRUITING)
• St Michael's Hospital Dun Laoighre — Dublin, Ireland (NOT_YET_RECRUITING)
• Tallaght University Hospital — Dublin, Ireland (NOT_YET_RECRUITING)
• University Hospital Galway — Galway, Ireland (NOT_YET_RECRUITING)
• St. Luke's Hospital — Kilkenny, Ireland (NOT_YET_RECRUITING)
• University Hospital Limerick — Limerick, Ireland (NOT_YET_RECRUITING)
• Midlands University Hospital — Tullamore, Ireland (NOT_YET_RECRUITING)
• University Hospital Waterford — Waterford, Ireland (RECRUITING)

Study contacts

• Principal investigator: Sean T Martin — St. James's Hospital, Ireland
• Study coordinator: Sean T Martin

Conditions: Pilonidal Sinus, Wound Healing, Negative Pressure Wound Therapy, Surgical Site Infection, Post-operative Complications, Health Economics, POSAS, CoPaQ