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Actively Recruiting

Phase 3
Age: 18Years - 99Years
All Genders
ID04292054

Study of Antibiotic Prophylaxis to Prevent Infections After Excision-Graft Surgery in Burn Patients with 5%-40% Burns

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-11-24

506

Participants Needed

1

Research Sites

11 weeks

Total Duration

AI-Summary

What this Trial Is About

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

Brief Title

Antibioprophylaxis for Excision-graft Surgery in Burn Patient (A2B-TRIAL)

Research Team

F

François DEPRET, MD

M

Matthieu LEGRAND, MD-PhD

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