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Can a vacuum dressing stop infections in high-risk leg fractures?

NCT ID NCT06337292

Disease control Sponsor: Major Extremity Trauma Research Consortium 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a negative pressure wound therapy (NPWT) device, placed over the surgical incision, can reduce infections and other wound complications compared to standard dressings in people with severe leg fractures. The trial will enroll 352 patients with high-risk tibia fractures. Participants are randomly assigned to receive either the NPWT device or a regular dressing, and their recovery is tracked for 3 months.

What this could mean

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

Active substance
incisional negative pressure wound therapy (NPWT) device
What this could lead to
If it works, this could become a standard way to prevent wound infections and complications after high-risk fracture surgery.
What could go wrong
This is a mid-stage trial with 352 patients, so results may not apply to everyone. The device may not reduce infections significantly more than standard dressings.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 352 people

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

Started

Jan 2025

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: 1. All open or closed tibial plateau or pilon fractures treated operatively with internal fixation at high risk for complication. Any open Gustilo Type I, II or IIIA tibial shaft fracture treated definitively with internal or external fixation with or without ipsilateral leg compartment syndrome if at least one wound is primarily closed. 2. We define high-risk fractures as those that are either: * Closed fracture initially treated with an external fixator (with or without limited internal fixation) and treated definitive more than 3 days later after swelling has resolved; * Any open type I, II or IIIA fracture, regardless of timing of definitive treatment; * Any tibial plateau fracture associated with ipsilateral leg compartment syndrome fasciotomy wounds that has at least one wound primarily closed 3. Requiring incision for fixation or debridement of 3 cm or greater. 4. Patients 18 years of age or older Exclusion Criteria: 1. The study injury is already infected at time of study enrollment. 2. Patient is unable to receive incisional NPWT for any reason. 3. Patients who have already had definitive fixation prior to enrollment in the study. 4. Severe problems with maintaining follow-up (e.g., patients who are homeless at the time of injury or those who are intellectually challenged without adequate family support or who are prisoners). 5. The study injury is a Gustilo Type IIIB or IIIC open fracture.

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Conditions

The condition(s) this trial relates to.

injury tibia fracture Wound Infection

As listed by the trial registrant

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

Fracture of tibia Infected wound Wound complication Wound dehiscence Wound heal

How to take part

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

  1. The places running it

    6 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

  • Dartmouth-Hitchcock Medical Center

    RECRUITING

    Lebanon, New Hampshire, 03756, United States

  • Inova Fairfax MEdical Campus

    RECRUITING

    Falls Church, Virginia, 22042, United States

  • UTHealth/McGovern Medical School

    RECRUITING

    Houston, Texas, 77030, United States

  • University of Maryland R Adams Cowley Shock Trauma Center

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Maryland Shock Trauma/Capitol Regions

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • Vanderbilt University

    RECRUITING

    Nashville, Tennessee, 37232, United States

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