Informations générales (source: ClinicalTrials.gov)
"Antibioprophylaxis for Excision-graft Surgery in Burn Patient: a Multicenter Randomized Double-blind Study: A2B Trial"
Interventional
Phase 3
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
octobre 2020
juillet 2026
02 décembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP Assistance publique - Hôpitaux de Paris | 18/04/2025 07:55:14 | Contacter | |||
| AP-HP - Hôpital Lariboisiere-Fernand Widal | |||||
| AP-HP - Hôpital Saint Louis | |||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Saint Louis Hospital - 75010 - Paris 2988507 - France | François Depret, PhD | Contact (sur clinicalTrials) | |||
Critères
Tous
- 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