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A2B-trial Antibioprophylaxis for excision-graft surgery in burn patient : a multicenter randomized double-bling study
EU CTIS ID: 2024-514349-13-00
What this study is testing
Evaluate the impact of systemic antibiotic prophylaxis on postoperative infections, sepsis and autograft lysis needing new skin autograft (within 7 days postoperatively) in burn patients.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - Major patient over 18 years
- - 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)
You likely can't join if
- - Proven severe allergy to cephalosporin or piperacilline-tazobactam or any other antibacterial agent of the penicillin class
- - known colonization of the burned area to be excised with tazocillin-resistant germ.
- - obese patient with BMI > 50 kg/m²
- - 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
See the full eligibility criteria
- - Major patient over 18 years
- - 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)
- - Proven severe allergy to cephalosporin or piperacilline-tazobactam or any other antibacterial agent of the penicillin class
- - known colonization of the burned area to be excised with tazocillin-resistant germ.
- - obese patient with BMI > 50 kg/m²
- - 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 or curatorship
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.