Clinical trial NCT06647290: ENVELOP: Wound Care Following Pilonidal Sinus Surgery
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pilonidal Sinus
Wound Healing
Keywords: Negative Pressure Wound Therapy
Surgical Site Infection
Post-operative Complications
Health Economics
POSAS
CoPaQ
EQ-5D-5L
Pain Score
Lead sponsor: Royal College of Surgeons, Ireland
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: Pilonidal sinus disease (PSD) is a chronic inflammatory condition of the skin and subcutaneous tissues arising from hair follicles in the natal cleft. The definitive aetiology of the condition is unknown, however, it is theorised that it is the result of either the obstruction and subsequent inflammation of hair follicles or secondary to hair penetrating through the skin into the subcutaneous tissue. This results in infection, abscess formation, chronic discharge and pain. PSD is a common condition affecting 26 per 10,000 population, with the prevalence reaching 1.1% in young adult males.

PSD causes a significant burden on healthcare services due to high rates of recurrence and readmission following surgery, together with negative impacts on patients' quality of life and self-image. An effective management strategy for the disease is necessary to ensure that post-operative outcomes are optimised and patient-reported outcomes are satisfactory in those whose PSD requires surgery.

The objective of this multicentre, national RCT is to prospectively investigate the effect of negative pressure wound therapy compared to leaving open with standard wound care on time to wound healing following surgical excision of chronic PSD.

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

Primary outcomes:
measure: Time to complete wound healing
timeFrame: 6 months post surgery
Secondary outcomes:
measure: Measure of post operative pain
timeFrame: 6 months post surgery
measure: Measure of post operative complications
timeFrame: 6 months post surgery
measure: Measure of quality of life
timeFrame: 6 months post surgery
measure: To investigate resource use
timeFrame: 6 months post surgery
measure: To compare recurrence rates
timeFrame: 6 months post surgery
measure: Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)
timeFrame: 1 month
measure: Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)
timeFrame: 3 months
measure: Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)
timeFrame: 6 months
measure: Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: 1 month
measure: Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: 3 months
measure: Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: 6 months
measure: Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)
timeFrame: 1 Month
measure: Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)
timeFrame: 3 Months
measure: Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)
timeFrame: 6 Months
measure: Health Economics evaluation of resource use and cost effectiveness using Negative Pressure Wound Therapy dressings
timeFrame: 6 Months
measure: Visual pain score questionnaire
timeFrame: Day of Surgery
measure: Visual pain score questionnaire
timeFrame: 1 Month
measure: Visual pain score questionnaire
timeFrame: 3 Months
Other outcomes:
Locations:
city: Castlebar
country: Ireland
facility: Mayo University Hospital
city: Cork
country: Ireland
facility: University Hospital Cork
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Dublin
country: Ireland
facility: St Michael's Hospital Dun Laoighre
city: Dublin
country: Ireland
facility: Tallaght University Hospital
city: Galway
country: Ireland
facility: University Hospital Galway
city: Kilkenny
country: Ireland
facility: St. Luke's Hospital
city: Limerick
country: Ireland
facility: University Hospital Limerick
city: Tullamore
country: Ireland
facility: Midlands University Hospital
city: Waterford
country: Ireland
facility: University Hospital Waterford
Study officials:
affiliation: St. James's Hospital, Ireland
name: Sean T Martin
role: PRINCIPAL_INVESTIGATOR
References: