Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06647290

ENVELOP: Wound Care Following Pilonidal Sinus Surgery

Led by Royal College of Surgeons, Ireland · Updated on 2024-10-17

200

Participants Needed

10

Research Sites

134 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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).

CONDITIONS

Official Title

ENVELOP: Wound Care Following Pilonidal Sinus Surgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants aged 18 years or older
  • Undergoing elective pilonidal sinus excision without primary closure
Not Eligible

You will not qualify if you...

  • Unable to adhere to protocol requirements such as completing questionnaires
  • Undergoing emergency drainage for a pilonidal abscess
  • Surgery for pilonidal sinus disease outside the natal cleft
  • Presence of underlying osteomyelitis
  • Presence of underlying fistulating disease such as Crohn's disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 10 locations

1

Mayo University Hospital

Castlebar, Ireland

Not Yet Recruiting

2

University Hospital Cork

Cork, Ireland

Not Yet Recruiting

3

Beaumont Hospital

Dublin, Ireland, H91 YR71

Not Yet Recruiting

4

St Michael's Hospital Dun Laoighre

Dublin, Ireland

Not Yet Recruiting

5

Tallaght University Hospital

Dublin, Ireland

Not Yet Recruiting

6

University Hospital Galway

Galway, Ireland

Not Yet Recruiting

7

St. Luke's Hospital

Kilkenny, Ireland

Not Yet Recruiting

8

University Hospital Limerick

Limerick, Ireland

Not Yet Recruiting

9

Midlands University Hospital

Tullamore, Ireland

Not Yet Recruiting

10

University Hospital Waterford

Waterford, Ireland

Actively Recruiting

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Research Team

S

Sean T Martin

CONTACT

E

Eanna Ryan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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