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Wound vacuum after pilonidal sinus surgery may cut healing time in half

NCT ID NCT06647290

Disease control Sponsor: Royal College of Surgeons, Ireland Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 20, 2026 · Last updated Jul 23, 2026 · Updated 3 times

Summary

This trial compares two ways to manage the wound after surgical removal of a chronic pilonidal sinus. Half of the 200 participants will receive a negative pressure wound therapy (NPWT) dressing that applies gentle suction to the wound, while the other half will receive standard open wound care. The main goal is to see which approach leads to faster complete wound healing.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
negative pressure wound therapy (NPWT) device
What this could lead to
If it works, this could offer a faster, less painful recovery for people with chronic pilonidal sinus disease after surgery.
What could go wrong
This is a mid-sized trial, and results may not apply to all patients. NPWT devices can be cumbersome and may not significantly improve healing over standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

injury pilonidal sinus Surgical Wound Infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pilonidal sinus Wound healing

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beaumont Hospital

    RECRUITING

    Dublin, Dublin, H91 YR71, Ireland

  • Mayo University Hospital

    RECRUITING

    Castlebar, Ireland

  • Midlands University Hospital

    RECRUITING

    Tullamore, Ireland

  • St James's Hospital

    RECRUITING

    Dublin, Ireland

  • St Michael's Hospital Dun Laoighre

    RECRUITING

    Dublin, Ireland

  • St Vincent's Hospital

    RECRUITING

    Dublin, Ireland

  • St. Luke's Hospital

    RECRUITING

    Kilkenny, Ireland

  • Tallaght University Hospital

    RECRUITING

    Dublin, Ireland

  • University Hospital Limerick

    RECRUITING

    Limerick, Ireland

  • University Hospital Waterford

    RECRUITING

    Waterford, Ireland

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