ENVELOP: Wound Care Following Pilonidal Sinus Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Negative Pressure Wound Therapy.
- Who it may be relevant to
- Registry conditions: Pilonidal Sinus, Wound Healing. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Ireland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Device Negative Pressure Wound Therapy
Application of a negative wound pressure therapy dressing to the wound post laparotomy
Primary outcome measures
- Time to complete wound healing [Time frame: 6 months post surgery]
Secondary outcome measures (12)
- Measure of post operative pain [Time frame: 6 months post surgery]
- Measure of post operative complications [Time frame: 6 months post surgery]
- Measure of quality of life [Time frame: 6 months post surgery]
- To investigate resource use [Time frame: 6 months post surgery]
- To compare recurrence rates [Time frame: 6 months post surgery]
- Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L) [Time frame: 1 month]
- Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L) [Time frame: 3 months]
- Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L) [Time frame: 6 months]
- Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS) [Time frame: 1 month]
- Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS) [Time frame: 3 months]
- Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS) [Time frame: 6 months]
- Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ) [Time frame: 1 Month]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Ireland · 10 centers
- Beaumont Hospital — Dublin
- Mayo University Hospital — Castlebar
- St James's Hospital — Dublin
- St Michael's Hospital Dun Laoighre — Dublin
- St Vincent's Hospital — Dublin
- Tallaght University Hospital — Dublin
- St. Luke's Hospital — Kilkenny
- University Hospital Limerick — Limerick
- … and 2 more centers
Identifiers
NCT: NCT06647290 · RCSI-ENVELOP