ENVELOP: Wound Care Following Pilonidal Sinus Surgery

Last updated: October 16, 2024
Sponsor: Royal College of Surgeons, Ireland
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Negative Pressure Wound Therapy

Clinical Study ID

NCT06647290
RCSI-ENVELOP
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

i) They are aged 18 years or older

ii) They are undergoing elective pilonidal sinus excision without primary closure

Exclusion

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

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Negative Pressure Wound Therapy
Phase:
Study Start date:
October 01, 2024
Estimated Completion Date:
April 27, 2027

Study 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.

Connect with a study center

  • Mayo University Hospital

    Castlebar,
    Ireland

    Site Not Available

  • University Hospital Cork

    Cork,
    Ireland

    Site Not Available

  • Beaumont Hospital

    Dublin, H91 YR71
    Ireland

    Site Not Available

  • St Michael's Hospital Dun Laoighre

    Dublin,
    Ireland

    Site Not Available

  • Tallaght University Hospital

    Dublin,
    Ireland

    Site Not Available

  • University Hospital Galway

    Galway,
    Ireland

    Site Not Available

  • St. Luke's Hospital

    Kilkenny,
    Ireland

    Site Not Available

  • University Hospital Limerick

    Limerick,
    Ireland

    Site Not Available

  • Midlands University Hospital

    Tullamore,
    Ireland

    Site Not Available

  • University Hospital Waterford

    Waterford,
    Ireland

    Active - Recruiting

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