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New dressing may keep amputation wounds clean and closed

NCT ID NCT03773575

Prevention Sponsor: Thomas Jefferson University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a vacuum dressing called PREVENA on 272 adults who had a leg amputated. The dressing applies gentle suction over the surgical cut to help it heal and prevent complications like infection, reopening, or fluid buildup. The goal was to see if this device reduces wound problems and medical costs compared to standard bandages.

What this could mean

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

Active substance
PREVENA™ PEEL & PLACE™ Dressing Kit (a vacuum dressing device)
What this could lead to
If it works, this could reduce wound complications like infection or reopening after leg amputation, potentially lowering hospital stays and repeat surgeries.
What could go wrong
This is a completed trial, but results may not apply to all patients or settings. The dressing is a device, not a drug, so benefits may be modest and depend on proper use.

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

272 people

The number who actually took part.

Started

Jan 2019

Finished

Aug 2024

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. Male or female adults 18 years or older 2. Patients undergoing above-knee amputation (includes the revision of emergency guillotine amputations) 3. Patients undergoing below-knee amputation (includes the revision of emergency guillotine amputations) 4. Informed Consent signed by patient Exclusion Criteria: 1. Minors under 18 years 2. Women who are pregnant or breastfeeding 3. Patients having BOTH legs amputated 4. Patients with sensitivity to silver 5. Unwilling or unable to provide informed consent 6. Inability to comply with planned study procedures

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Conditions

The condition(s) this trial relates to.

Seroma Surgical Wound Infection

As listed by the trial registrant

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

Amputation Amputation; postoperative, sequelae Lymph leakage SEROMA Wound dehiscence Wound infection, surgical

Contacts and locations

Locations

  • Gemelli Hospital

    Roma, RM, 8, 00168, Italy

  • Thomas Jefferson University/Hospital

    Philadelphia, Pennsylvania, 19107, United States

  • Westchester Medical Center

    Valhalla, New York, 10595, United States

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