NCT06647290

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
12mo left

Started Oct 2024

Typical duration for not_applicable

Geographic Reach
1 country

10 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Oct 2024Apr 2027

First Submitted

Initial submission to the registry

November 28, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 17, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2027

Last Updated

October 17, 2024

Status Verified

September 1, 2024

Enrollment Period

2 years

First QC Date

November 28, 2023

Last Update Submit

October 16, 2024

Conditions

Pilonidal SinusWound Healing

Keywords

Negative Pressure Wound TherapySurgical Site InfectionPost-operative ComplicationsHealth EconomicsPOSASCoPaQEQ-5D-5LPain Score

Outcome Measures

Primary Outcomes (1)

  • Time to complete wound healing

    Number of days to complete epithelialisation or closure of the wound without any discharge, drainage, scab, and/or the requirement for further dressing. The quality of wound healing will be assessed using a validated patient and observer reported scar assessment tool-POSAS.

    6 months post surgery

Secondary Outcomes (18)

  • Measure of post operative pain

    6 months post surgery

  • Measure of post operative complications

    6 months post surgery

  • Measure of quality of life

    6 months post surgery

  • To investigate resource use

    6 months post surgery

  • To compare recurrence rates

    6 months post surgery

  • +13 more secondary outcomes

Study Arms (2)

Negative Pressure Wound Therapy

EXPERIMENTAL

The wound is dressed using negative pressure wound therapy.

Device: Negative Pressure Wound Therapy

Standard Wound dressing

ACTIVE COMPARATOR

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

Device: Negative Pressure Wound Therapy

Interventions

Negative Pressure Wound TherapyDEVICE

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

Negative Pressure Wound TherapyStandard Wound dressing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • i) They are aged 18 years or older
  • ii) They are undergoing elective pilonidal sinus excision without primary closure

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Mayo University Hospital

Castlebar, Ireland

NOT YET RECRUITING

University Hospital Cork

Cork, Ireland

NOT YET RECRUITING

Beaumont Hospital

Dublin, H91 YR71, Ireland

NOT YET RECRUITING

St Michael's Hospital Dun Laoighre

Dublin, Ireland

NOT YET RECRUITING

Tallaght University Hospital

Dublin, Ireland

NOT YET RECRUITING

University Hospital Galway

Galway, Ireland

NOT YET RECRUITING

St. Luke's Hospital

Kilkenny, Ireland

NOT YET RECRUITING

University Hospital Limerick

Limerick, Ireland

NOT YET RECRUITING

Midlands University Hospital

Tullamore, Ireland

NOT YET RECRUITING

University Hospital Waterford

Waterford, Ireland

RECRUITING

MeSH Terms

Conditions

Pilonidal SinusSurgical Wound Infection

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

CystsNeoplasmsWound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DrainageTherapeuticsSurgical Procedures, OperativeWound Closure Techniques

Study Officials

  • Sean T Martin

    St. James's Hospital, Ireland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sean T Martin

CONTACT

(01) 261 4037seanmartin@rcsi.ie

Eanna Ryan

CONTACT

(01) 261 4037eannaryan@rcsi.ie

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2023

First Posted

October 17, 2024

Study Start

October 1, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

April 27, 2027

Last Updated

October 17, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

IE(10)