Actively Recruiting
Antibioprophylaxis for Excision-graft Surgery in Burn Patient (A2B-TRIAL)
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-11-24
506
Participants Needed
1
Research Sites
299 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Antibioprophylaxis for Excision-graft Surgery in Burn Patient (A2B-TRIAL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 emergency law provisions
You will not qualify if you...
- Severe allergy to cephalosporin, piperacillin-tazobactam, or any penicillin-class antibiotic
- History of severe allergic reaction to beta-lactams such as cephalosporins, monobactams, or carbapenems
- Receiving antibiotic therapy at the time of surgery
- Pregnant or breastfeeding
- Not covered by social security
- Transferred from another burn unit
- Participating in another investigational drug study on the primary endpoint
- Local or systemic infection requiring antibiotic therapy
- Under guardianship or curatorship
- Burned area colonized with tazocillin-resistant bacteria
- Obese with BMI greater than 50 kg/m²
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Saint Louis Hospital
Paris, France, 75010
Actively Recruiting
Research Team
F
François DEPRET, MD
CONTACT
M
Matthieu LEGRAND, MD-PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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