The A2B trial, antibiotic prophylaxis for excision-graft surgery in burn patients: a multicenter randomized double-blind study.
François Dépret, Boris Farny, Mathieu Jeanne...
https://pubmed.ncbi.nlm.nih.gov/33239101Actively Recruiting
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-11-24
506
Participants Needed
1
Research Sites
11 weeks
Total Duration
Researchers are investigating whether giving systemic antibiotics before surgery can lower the risk of infections after excision-graft surgery in burn patients. This study focuses on adults with burns covering 5% to 40% of their body surface area who require at least one excision surgery graft. The question arises because antibiotic use carries risks like antibiotic resistance and side effects, and current guidelines on prophylactic antibiotics in burn surgery vary widely without clear consensus. Participants are randomly assigned to receive either antibiotic prophylaxis or a placebo before surgery. If their burned area is not colonized by Pseudomonas aeruginosa, they receive cefazolin 2g by intravenous infusion over 30 minutes. If colonized by Pseudomonas aeruginosa, they receive piperacillin-tazobactam 4g in the same way. The control group receives a saline placebo infusion. Antibiotics or placebo are administered 30 minutes before the surgical incision. During the study, patients are monitored in intensive care or burn centers where vital signs, infection scores, medical history, treatments, and bacterial colonization are recorded. Follow-up visits occur at 7, 28, and 90 days after surgery to track infections, graft outcomes, hospital stay length, and antibiotic use. The primary focus is on infections and graft problems within 7 days post-surgery, with longer-term follow-up by phone or medical team contact if discharged. The study duration per patient is up to 90 days.
CONDITIONS
Antibioprophylaxis for Excision-graft Surgery in Burn Patient (A2B-TRIAL)
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Single dose on the day of surgery
Participants receive antibiotic prophylaxis or placebo 30 minutes before excision-graft surgery of burn wounds.
1 surgical visit (in-person)
Duration - Up to 90 days after surgery
Participants are monitored for post-operative infection, sepsis, surgical site infection, graft lysis, and other outcomes after surgery.
Visits at approximately 7 days, 28 days, and 90 days post-surgery; the 90-day visit may be conducted by telephone if discharged
Total: 1 location
1
Saint Louis Hospital
Paris, France, 75010
Actively Recruiting
F
François DEPRET, MD
M
Matthieu LEGRAND, MD-PhD
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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François Dépret, Boris Farny, Mathieu Jeanne...
https://pubmed.ncbi.nlm.nih.gov/33239101