ENVELOP: Wound Care Following Pilonidal Sinus Surgery
ENVELOP
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
1 other identifier
interventional
200
1 country
10
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2024
Typical duration for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2023
CompletedStudy Start
First participant enrolled
October 1, 2024
CompletedFirst Posted
Study publicly available on registry
October 17, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
September 24, 2026
July 1, 2026
2.2 years
November 28, 2023
September 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to complete wound healing
Number of days to complete epithelialisation or closure of the wound without any discharge, drainage, scab, and/or the requirement for further dressing.
Up to 6 months post surgery
Secondary Outcomes (7)
Measure of post operative pain
Day of surgery, 28 days post surgery & 3 months post surgery
Measure of post operative complications
6 months post surgery
To compare recurrence rates
6 months post surgery
Cost-effectiveness
6 months post surgery
Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)
Baseline, 1 month, 3 months & 6 months
- +2 more secondary outcomes
Study Arms (2)
Negative Pressure Wound Therapy
EXPERIMENTALThe wound is dressed using negative pressure wound therapy.
Standard wound care (SWC)
ACTIVE COMPARATORFollowing excision, the wound is left open (no primary closure) and managed with standard dressings according to local protocol, with wound healing by secondary intention.
Interventions
Following elective excision of chronic pilonidal sinus disease with the wound left open, NPWT is applied in theatre using a polyurethane foam-based system (e.g. VAC, Renasys-GO, Prevena or equivalent) cut to fit the wound cavity, sealed with an adhesive drape and connected to a portable pump at -125 mmHg continuous pressure. Dressings are changed every 48-72 hours in clinic until granulation reaches skin level, followed by standard dressings until epithelialisation.
Eligibility Criteria
You may qualify if:
- i) They are aged 18 years or older
- ii) They are undergoing elective pilonidal sinus excision without primary closure
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Mayo University Hospital
Castlebar, Ireland
Beaumont Hospital
Dublin, D09V2N0, Ireland
St James's Hospital
Dublin, Ireland
St Michael's Hospital, Dún Laoghaire
Dublin, Ireland
St Vincent's Univeristy Hospital
Dublin, Ireland
Tallaght University Hospital
Dublin, Ireland
St. Luke's Hospital
Kilkenny, Ireland
University Hospital Limerick
Limerick, Ireland
Midlands University Hospital
Tullamore, Ireland
University Hospital Waterford
Waterford, Ireland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sean T Martin
St. James's Hospital, Ireland
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Central blinded adjudication of standardised wound photographs; analyses blinded to allocation.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 28, 2023
First Posted
October 17, 2024
Study Start
October 1, 2024
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
June 1, 2027
Last Updated
September 24, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share