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Could a vacuum dressing prevent infections after leg amputation?

NCT ID NCT06025253

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time

Summary

This trial investigates whether a single-use negative pressure wound therapy (NPWT) device, which applies gentle suction to the closed incision, can reduce surgical site infections, wound complications, and improve scar appearance compared to standard dressings after major lower limb amputation. About 728 adults undergoing below-knee, through-knee, or above-knee amputation for any reason will be randomly assigned to receive either the NPWT device or a standard wound dressing. The study will track wound healing problems, hospital stay length, readmission rates, and quality of life.

What this could mean

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

Active substance
a single-use negative pressure wound therapy device applied to the closed incision after major leg amputation
What this could lead to
If effective, this device could become a standard way to prevent wound infections and complications after major leg amputations, improving recovery and scar appearance.
What could go wrong
This is a large trial, but the device may not reduce infections significantly compared to standard dressings, and some patients may find it uncomfortable or develop skin irritation.

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 728 people

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

Started

Mar 2024

Expected to finish

Dec 2028

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: * Patients aged 18 years or older; * Patients undergoing major lower extremity amputation, including below-knee amputation, through-knee amputation and above-knee amputation, for any indication; * Patients with primary closure of the surgical incision using either interrupted or continuous sutures Exclusion Criteria: * Patients \<18 years; * Women who are pregnant and/or breast-feeding; * Patients with amputations performed without primary skin closure, including guillotine amputations, amputations deliberately left open for drainage purposes and amputations with soft tissues defects at the stump; * Patients with amputations where skin glue is the only means of skin closure * Patients with a clinically absent femoral pulse

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Conditions

The condition(s) this trial relates to.

injury Surgical Wound Surgical Wound Infection Wound Infection

As listed by the trial registrant

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

Cosmesis Wound infection Wound surgical

How to take part

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

  1. The places running it

    7 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, Beaumont Rd,Dublin 9, D09V2N0

    RECRUITING

    Dublin, Dublin, H91 YR71, Ireland

  • St James's Hospital

    RECRUITING

    Dublin, Ireland

  • St Vincents University Hospital

    RECRUITING

    Dublin, Ireland

  • Tallaght University Hospital

    RECRUITING

    Dublin, Ireland

  • University Hospital Galway

    RECRUITING

    Galway, Ireland

  • University Hospital Limerick

    RECRUITING

    Limerick, Ireland

  • University Hospital Waterford

    RECRUITING

    Waterford, Ireland

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