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
DeviceFollowing 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.
Standard wound care
Other interventionStandard wound care
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Negative Pressure Wound TherapyExperimental treatment 1 intervention
Group B: Standard wound care (SWC)Active 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.
Time frame
Up to 6 months post surgerySecondary outcomes
1
Measure of post operative pain
Pain measured by visual analogue pain scale (0 = no pain, 10 = worst pain) at rest, on walking and on sitting
Time frame
Day of surgery, 28 days post surgery & 3 months post surgery2
Measure of post operative complications
Post-operative complications, including surgical site infection (CDC criteria), seroma, abscess, readmission and return to theatre.
Time frame
6 months post surgery3
To compare recurrence rates
To compare the 6-month recurrence rates (recurrence being defined as the development of a new sinus or abscess within the natal cleft occurring after wound healing had been achieved) between the NPWT and SWC Groups
Time frame
6 months post surgery4
Cost-effectiveness
Within-trial cost-utility analysis from health-system and patient perspectives, expressed as incremental cost per QALY gained (QALYs from EQ-5D-5L, area under the curve). Resource use includes hospital and community contacts, dressing changes, complications, readmissions and returns to theatre, valued at Irish unit costs; patient costs and productivity losses via CoPaQ.
Time frame
6 months post surgerySponsors and contacts
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Source ClinicalTrials.gov