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

NCT04292054 | Recruiting Phase 3 DMC

• 1 other identifier: APHP180605
• Study Type: interventional
• Target: 506
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns Surgery

Keywords

Antibioprophylaxis; sepsis; infection; graft lysis

Outcome Measures

Primary Outcomes (4)

• Post-operative infection defined as Post-operative sepsis and/or Surgical site infection, and/or Graft lysis requiring a new graft within 7 days after surgery.

  Postoperative infection will be collected by the intensivists or infectious disease specialist consultant blinded to the interventional or control arm. Skin infection and skin graft lysis requiring a new graft procedure will be assess by a surgeon blinded of the arm of the study.

  7 days after surgery

• Post-operative sepsis

  Sepsis is defined as life-threatening organ dysfunction (defined by an increase of Sepsis related organ failure assessment \[SOFA\] score of 2 points or more) in response to infection. The minimum value is 0 and maximum value is 24. 0 meaning no organ dysfunction and 24 the maximum organ dysfunction.

  7 days after surgery

• Surgical site infection

  Surgical site (operated skin) infection with general signs is considered as a systemic infection originated from skin (Presence of a local or loco-regional inflammatory reaction; Unfavourable and unexpected local evolution; Lysis of grafts; Necrosis of fat located under the graft)

  7 days after surgery

• Graft lysis needing a new graft procedure

  Graft lysis is defined as a skin graft lysis in the 7 days post operative, and needing a new skin graft assessed be a surgeon blinded of the randomization group.

  7 days after surgery

Secondary Outcomes (8)

• Mortality

  At day 90

• Skin graft lysis requiring a new graft procedure

  7 days after surgery

• Postoperative bacteremia

  within 7 days of surgery

• Post-operative pulmonary infection

  7 days after surgery

• Post-operative surgical site infection

  7 days after surgery

Study Arms (2)

active group

ACTIVE COMPARATOR

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.

Drug: active intervention

Placebo group

PLACEBO COMPARATOR

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.

Other: placebo intervention

Interventions

active intervention 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.

Also known as: Cefazolin or piperacilline-tazobactam 4 g

active group

placebo intervention 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.

Also known as: NaC 0,9%l

Placebo group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Saint Louis Hospital

Paris, 75010, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 33239101 DERIVED

MeSH Terms

Conditions

Sepsis; Infections

Interventions

Cefazolin

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• François DEPRET, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

François DEPRET, MD

CONTACT

01 42 49 95 70; francois.depret@aphp.fr

Matthieu LEGRAND, MD-PhD

CONTACT

01 42 49 95 70; matthieu.m.legrand@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Treatments will be conditioned by the Contract manufacturing organization (central pharmacy of Assistance-Publique Hôpitaux de Paris) according to a list provided by an independent person and assigning a treatment arm to each treatment number
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind, randomized controlled study with two arms (1:1) Arm 1 : With antibiotic prophylaxis strategy, (cefazolin) if absence of colonization to Pseudomonas aeruginosa; or (piperacilline-tazobactam) if the burn is colonized with Pseudomonas aeruginosa. Arm 2 : Without antibiotic prophylaxis strategy (placebo)

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: March 2, 2020
• Study Start: October 11, 2020
• Primary Completion: April 18, 2026
• Study Completion (Estimated): July 9, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)