ENVELOP: Wound Care Following Pilonidal Sinus Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2027-04-27

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Pilonidal Sinus Wound Healing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Negative Pressure Wound Therapy

The wound is dressed using negative pressure wound therapy.

Group Type EXPERIMENTAL

Negative Pressure Wound Therapy

Intervention Type DEVICE

Application of a negative wound pressure therapy dressing to the wound post laparotomy

Standard Wound dressing

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

Group Type ACTIVE_COMPARATOR

Negative Pressure Wound Therapy

Intervention Type DEVICE

Application of a negative wound pressure therapy dressing to the wound post laparotomy

Interventions

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Negative Pressure Wound Therapy

Application of a negative wound pressure therapy dressing to the wound post laparotomy

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sean T Martin

Role: PRINCIPAL_INVESTIGATOR

St. James's Hospital, Ireland

Locations

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