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

NCT04292054 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 506

Last updated 2025-11-24

No results posted yet for this study

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-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

  • Burns Surgery

Interventions

DRUG

active intervention

The antibiotic prophylaxis will be cefazolin 2 g, or piperacilline-tazobactam 4 g, powder for solution for injection diluted in 50mL of NaCl 0.9%, IV infusion on 30 minutes with syringe pump.

OTHER

placebo intervention

The control group will received, as placebo NaCl 0.9% solution for injection diluted in 50mL of NaCl 0.9%, IV infusion on 30 minutes with syringe pump.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • François DEPRET, MD · Department of Anesthesiology, Critical Care and Burn Unit; Saint-Louis hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-11
Primary Completion
2026-04-18
Completion
2026-07-09

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04292054 on ClinicalTrials.gov