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Suction bandage may keep groin wounds clean after surgery

NCT ID NCT02581904

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 device called Prevena, a sterile sponge that applies gentle suction to a closed surgical wound for 5-7 days after groin surgery. The goal was to see if it lowers the chance of wound infections, reopening, or fluid leaks compared to a standard dry gauze dressing. The trial included 140 high-risk patients undergoing vascular surgery through a groin incision.

What this could mean

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

Active substance
Prevena closed incision negative pressure device
What this could lead to
If it works, this could give surgeons a simple way to prevent wound infections and other complications after groin surgery.
What could go wrong
This is a small, single-center trial with only 140 participants, so results may not apply to all patients. The device is already approved, so the benefit over standard care may be modest.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

140 people

The number who actually took part.

Started

Jan 2015

Finished

Apr 2017

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 to 100 years

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: * All patients undergoing a femoral incision during vascular reconstruction or repair will be considered for study Exclusion Criteria: * Emergency procedure * Unable to give informed consent

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Conditions

The condition(s) this trial relates to.

Aneurysm peripheral arterial disease Surgical Wound Dehiscence Wound Infection

As listed by the trial registrant

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

Aneurysm Peripheral arterial disease Surgical wound dehiscence Wound infection

Contacts and locations

Locations

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.