RECRUITINGPhase 3INTERVENTIONAL

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

"Antibioprophylaxis for Excision-graft Surgery in Burn Patient: a Multicenter Randomized Double-blind Study: A2B Trial"

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form or inclusion under the emergency provisions of the law (article L1122-1-2 of the CSP) Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

active intervention

The antibiotic prophylaxis will be cefazolin 2 g, or piperacilline-tazobactam 4 g, powder for solution for injection diluted in 50mL of NaCl 0.9%, IV infusion on 30 minutes with syringe pump.

OTHER

placebo intervention

The control group will received, as placebo NaCl 0.9% solution for injection diluted in 50mL of NaCl 0.9%, IV infusion on 30 minutes with syringe pump.

Locations (1)

Saint Louis Hospital

Paris, France