ENVELOP: Wound Care Following Pilonidal Sinus Surgery

Royal College of Surgeons, Ireland

Status: Enrolling

Conditions: Wound Healing; Pilonidal Sinus

Treatments: Device: Negative Pressure Wound Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06647290

RCSI-ENVELOP

Details and patient eligibility

About

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).

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Negative Pressure Wound Therapy

Experimental group

Description:

The wound is dressed using negative pressure wound therapy.

Treatment:

Device: Negative Pressure Wound Therapy

Standard Wound dressing

Active Comparator group

Description:

After the skin is closed, the wound is covered using sterile standard gauze dressing.

Treatment:

Device: Negative Pressure Wound Therapy