Status:
RECRUITING
Antibioprophylaxis for Excision-graft Surgery in Burn Patient (A2B-TRIAL)
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Burns Surgery
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
Brief 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-opera...
Detailed Description
The intensive care unit investigator will verify the inclusion and non-inclusion criteria. The following parameters will be collected at ICU/burn centers: Hemodynamic parameters; sepsis organ failure...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 9 2026
Estimated Enrollment :
506 Patients enrolled
Trial Details
Trial ID
NCT04292054
Start Date
October 11 2020
End Date
July 9 2026
Last Update
November 24 2025
Active Locations (1)
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1
Saint Louis Hospital
Paris, France, 75010