Antibioprophylaxis for Excision-graft Surgery in Burn Patient (A2B-TRIAL)

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Burns Surgery

In brief

The indication of antibiotic prophylaxis in burn patients remains highly controversial and hasn't reached a consensus. The objective of antibiotic prophylaxis would be to reduce the risk of post-operative local and systemic infections. Burn surgery is associated with a high risk of bacteremia and postoperative infections and sepsis. However, antibiotic prophylaxis exposes to the risk of selecting drug-resistant pathogens as well as adverse effects of antibiotics (i.e Clostridium difficile colitis). Recommendations regarding perioperative prophylaxis using systemic antibiotics vary across sources. The lack of data precludes any international strong recommendations regarding the best strategy regarding antibiotic prophylaxis. The goal of this project is therefore to determine whether peri-operative systemic antibiotics prophylaxis could reduce the incidence of post-operative infections in burn patients.

Key facts

Study ID

NCT04292054

Run by

Assistance Publique - Hôpitaux de Paris

People needed

506

Starts

2020-10-11

Expected to finish

2026-07-09

Last updated by the study team

2025-11-24

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Saint Louis Hospital — Paris, France (enrolling)

Full record on ClinicalTrials.gov

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