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NCT Number: NCT04292054

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

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.

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Key information

Conditions

Burns Surgery Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Saint Louis Hospital

Paris, 75010, France

Location status: Recruiting

Location contact

François Depret, PhD

CONTACT

[email protected]

+33171207559

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Cefazolin or piperacilline-tazobactam 4 g

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.

Other names: NaC 0,9%l

Primary outcomes

  1. 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.

    Time frame: 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.

  2. Post-operative sepsis

    Time frame: 7 days after surgery

    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.

  3. Surgical site infection

    Time frame: 7 days after surgery

    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)

  4. Graft lysis needing a new graft procedure

    Time frame: 7 days after surgery

    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.

Secondary outcomes

  1. Mortality

    Time frame: At day 90

    Any death occurring between randomization and D 90

  2. Skin graft lysis requiring a new graft procedure

    Time frame: 7 days after surgery

    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.

  3. Postoperative bacteremia

    Time frame: within 7 days of surgery

    Positive blood culture .

  4. Post-operative pulmonary infection

    Time frame: 7 days after surgery

    Imaging Test Evidence

    Two or more serial chest imaging test results with at least one of the following:

    New and persistent or Progressive and persistent

    • Infiltrate
    • Consolidation
    • Cavitation Signs/Symptoms/Laboratory

    For ANY PATIENT, at least one of the following:

    • Fever (>38.0°C or >100.4°F)
    • Leukopenia (≤4000 WBC/mm) or leukocytosis (>12,000 WBC/mm)
    • For adults >70 years old, altered mental status with no other recognized cause

    And at least two of the following:

    • New onset of purulent sputum or change in character of sputum, or increased respiratory secretions, or increased suctioning requirements
    • New onset or worsening cough, or dyspnea, or tachypnea
    • Rales or bronchial breath sounds
    • Worsening gas exchange

  5. Post-operative surgical site infection

    Time frame: 7 days after surgery

    Skin infection with general signs is considered as a systemic infection originated from skin.

  6. Number of hospitalization days living without antibiotic therapy

    Time frame: at Day 28 and Day 90

    It will be calculated as the number of survival days without antibiotic therapy respectively between randomization and day 28 and day 90.

  7. Number of days of hospitalization until complete healing (> 95% total burn surface area)

    Time frame: at Day 28 and Day 90

    It will be calculated by the number of days between ICU complete healing and ICU discharge.

  8. Number of patients with a colonization with a multidrug resistant bacteria.

    Time frame: at Day 28 and Day 90

    It will be defined as :

    AmpC producer enterobacteriacae Extended spectrum beta lactamase enterobacteriacae Carbapenemase producer enterobacteriacae Meticillin resistant aureus staphylococcus Vancomycine resistant enterococcus Piperacillin-Tazobactam resistant bacteria Imipenem resistant Acinetobacter Baumanii. And it will be mesured from results of bacterial cultures and/or genotyping with antibiogramm resistance profile

Study contacts

Contact information is provided by the study sponsor or research team.

François DEPRET, MD

CONTACT

[email protected]

01 42 49 95 70 ext. 00 33

Matthieu LEGRAND, MD-PhD

CONTACT

[email protected]

01 42 49 95 70 ext. 00 33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

"Antibioprophylaxis for Excision-graft Surgery in Burn Patient: a Multicenter Randomized Double-blind Study: A2B Trial"

Acronym: A2B

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Mar 2, 2020
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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