ENVELOP: Wound Care Following Pilonidal Sinus Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRoyal College of Surgeons, Ireland
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Negative Pressure Wound Therapy
DeviceApplication of a negative wound pressure therapy dressing to the wound post laparotomy
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Negative Pressure Wound TherapyExperimental treatment 1 intervention
Group B: Standard Wound dressingActive comparator 1 intervention
Trial outcomes
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. The quality of wound healing will be assessed using a validated patient and observer reported scar assessment tool-POSAS.
Time frame
6 months post surgerySecondary outcomes
1
Measure of post operative pain
Pain measured by visual analogue pain scores which is a scale from 1 (no pain) to 10 (worst pain), between the NPWT and SWC Groups.
Time frame
6 months post surgery2
Measure of post operative complications
Measure of post operative complications between the NPWT and SWC Groups
Time frame
6 months post surgery3
Measure of quality of life
To compare quality-of-life differences between the two groups from the time of surgery until wound healing is achieved using the
Time frame
6 months post surgery4
To investigate resource use
To investigate resource use and thereby cost effectiveness of NPWT versus standard wound care
Time frame
6 months post surgerySponsors and contacts
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Source ClinicalTrials.gov