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Burn surgery infection risk: do antibiotics help or hurt?

NCT ID NCT04292054

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 giving antibiotics before burn surgery lowers the chance of infections after the operation. About 506 adults with burns covering 5% to 40% of their body will take part. Half will get antibiotics before surgery, and half will get a placebo. The goal is to see if antibiotics reduce infections, sepsis, or the need for another skin graft.

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 506 people

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

Started

Oct 2020

Expected to finish

Jul 2026

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 to 99 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: * Patient over 18 years and less than 80 years old * Burned patients requiring at least one excision-graft surgery * Burn TBSA% between 5% and 40% * Signed informed consent or inclusion under the emergency provisions of the law (article L1122-1-2 of the CSP) Exclusion Criteria: * Proven severe allergy to cephalosporin or piperacilline-tazobactam or any other antibacterial agent of the penicillin class * History of severe allergic reaction to any other beta-lactam (eg cephalosporins, monobactams or carbapenems). * Patient on antibiotic therapy at the time of surgery * Pregnant or breast-feeding patient * Patient not covered by the social security * Patient transferred from another burn Unit * Patient participant in investigational competitive medicinal product study on the primary endpoint * Patient with local or systemic signs of infection requiring systemic antimicrobial therapy * Patient under guardianship * Patient under curatorship * known colonization of the burned area to be excised with tazocillin-resistant germ. * obese patient with BMI \> 50 kg/m²

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Conditions

The condition(s) this trial relates to.

burn Infections injury Sepsis

As listed by the trial registrant

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

Burns surgery

How to take part

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

  1. The places running it

    1 site. 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

  • Saint Louis Hospital

    RECRUITING

    Paris, 75010, France

More trials for these conditions

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