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

NCT ID: NCT04292054

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 506 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-11
• Study Completion Date: 2026-07-09

Brief 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.

Detailed Description

The intensive care unit investigator will verify the inclusion and non-inclusion criteria.

The following parameters will be collected at ICU/burn centers: Hemodynamic parameters; sepsis organ failure assessment (SOFA) score, Glasgow Coma scale; Medical history / comorbidities; Concomitant treatment; Burn wound bacterial colonization; Biological parameters.

The inclusion and randomization will be performed as late as possible before the first surgical procedure.

Randomization: Burn patients with deep burn between 5 to 40% TBSA requiring at least one excision surgery graft will be randomized to receive antibioprophylaxis (or placebo) 30 minutes before the incision with either first generation cephalosporin (cefazolin) (if absence of colonization to Pseudomonas aeruginosa); or piperacillin-tazobactam (if the burned area is colonized with Pseudomonas aeruginosa). We chose to target specifically Pseudomonas aeruginosa because it has been associated with significant morbidity and risk of graft lysis in burn patients.

No specific exams are required during the 7 days, 28 days and 90 days follow up visits.

The end of research visit is the 90-day follow-up visit. If the patient has been discharged from the hospital, the 90-day visit will consist of a telephone contact with the patient if he or she has been discharged home or with the medical team of the healthcare structure if the patient has been discharged to another structure.

Conditions

Burns Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

active group

The antibiotic prophylaxis will be cefazolin 2 g powder for solution for injection diluted in 50mL of NaCl 0.9%, IV infusion on 30 minutes with syringe pump, in case of absence of colonization to Pseudomonas aeruginosa prior to the surgical procedure.

The dose administer is 2g.

Antibiotic prophylaxis will be piperacilline-tazobactam 4 g powder for solution for injection diluted in 50mL of NaCl 0.9%, IV infusion on 30 minutes with syringe driver in patients with burn wound colonized to Pseudomonas aeruginosa.

The dose administer is 4g.

Group Type: ACTIVE_COMPARATOR

active intervention

Intervention Type: DRUG

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.

Placebo group

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.

Group Type: PLACEBO_COMPARATOR

placebo intervention

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Other Intervention Names

Cefazolin or piperacilline-tazobactam 4 g; NaC 0,9%l

Eligibility Criteria

Inclusion Criteria

• 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 the emergency provisions of the law (article L1122-1-2 of the CSP)

Exclusion Criteria

• Proven severe allergy to cephalosporin or piperacilline-tazobactam or any other antibacterial agent of the penicillin class
• 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
• Patient under curatorship
• known colonization of the burned area to be excised with tazocillin-resistant germ.
• obese patient with BMI > 50 kg/m²

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

François DEPRET, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, Critical Care and Burn Unit; Saint-Louis hospital

Locations

Saint Louis Hospital

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

François DEPRET, MD

Role: CONTACT

francois.depret@aphp.fr

01 42 49 95 70 ext. 00 33

Matthieu LEGRAND, MD-PhD

Role: CONTACT

matthieu.m.legrand@gmail.com

01 42 49 95 70 ext. 00 33

Facility Contacts

François Depret, PhD

Role: primary

francois.depret@aphp.fr

+33171207559

References

Depret F, Farny B, Jeanne M, Klouche K, Leclerc T, Nouette-Gaulain K, Pantet O, Remerand F, Roquilly A, Rousseau AF, Sztajnic S, Wiramus S, Vicaut E, Legrand M; A2B trial investigators. The A2B trial, antibiotic prophylaxis for excision-graft surgery in burn patients: a multicenter randomized double-blind study. Trials. 2020 Nov 25;21(1):973. doi: 10.1186/s13063-020-04894-y.

Reference Type: DERIVED

PMID: 33239101 (View on PubMed)

Other Identifiers

APHP180605

Identifier Type: -

Identifier Source: org_study_id