ENVELOP: Wound Care Following Pilonidal Sinus Surgery

NCT ID
NCT06647290
Registry status
Recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
Royal College of Surgeons, Ireland
Conditions
Pilonidal Sinus, Wound Healing

Overview

ClinicalTrials.gov lists this study as Recruiting.

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

Enrollment: 200 participants (Estimated).

What is being studied

  • Intervention: Drainage
  • Device: Negative Pressure Wound Therapy
  • Intervention: Negative-Pressure Wound Therapy
  • Other: Standard wound care
  • Intervention: Surgical Procedures, Operative
  • Intervention: Therapeutics
  • Intervention: Wound Closure Techniques

Who may be eligible

Ages
18 Years to no maximum
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following 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 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

Study locations

10 study locations are listed.

Recruiting site status is explicitly provided for 10 locations; 10 are listed as Recruiting.

Countries: Ireland

Sample of listed locations

  • Mayo University Hospital — Castlebar, Ireland — Recruiting
  • Beaumont Hospital — Dublin, D09V2N0, 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
  • 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 details

Start date
October 1, 2024
Primary completion date
December 1, 2026
Completion date
June 1, 2027
First posted
October 17, 2024

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT06647290
Registry last updated
September 24, 2026
QualifiedStudies registry data refreshed
September 28, 2026
QualifiedStudies record fetched
September 28, 2026

View NCT06647290 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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