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

• Status: Recruiting
• Trial end date: 2025-01-09
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Cefazolin; Pharmaceutical Solutions; Piperacillin; Tazobactam

Criteria

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 inclusion

• 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 guardian ship

• Patient under curatorship

• Known colonization of the burned area to be excised with tazocillin-resistant germ.

• Obese patient