Actively Recruiting

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

Antibioprophylaxis for Excision-graft Surgery in Burn Patients A Multicenter Randomized Double-blind Study (A2B Trial)

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

506

Participants Needed

1

Research Sites

11 weeks

Total Duration

On this page

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)

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient over 18 years and less than 80 years old
  • Burn patients requiring at least one excision-graft surgery
  • Burn total body surface area (TBSA) between 5% and 40%
  • Signed informed consent or inclusion under emergency law provisions
Not Eligible

You will not qualify if you...

  • Severe allergy to cephalosporin, piperacillin-tazobactam, or other penicillin-class antibacterial agents
  • History of severe allergic reaction to other beta-lactams (cephalosporins, monobactams, carbapenems)
  • Currently on antibiotic therapy at time of surgery
  • Pregnant or breastfeeding
  • Not covered by social security
  • Transferred from another burn unit
  • Participating in another investigational drug study on the primary endpoint
  • Having local or systemic infection requiring systemic antibiotics
  • Under guardianship or curatorship
  • Known colonization of burn area with tazocillin-resistant bacteria
  • Obese with BMI over 50 kg/m²

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Treatment

Duration - Single dose on the day of surgery

Participants receive antibiotic prophylaxis or placebo 30 minutes before excision-graft surgery of burn wounds.

1 surgical visit (in-person)

Follow-up

Duration - Up to 90 days after surgery

Participants are monitored for post-operative infection, sepsis, surgical site infection, graft lysis, and other outcomes after surgery.

Visits at approximately 7 days, 28 days, and 90 days post-surgery; the 90-day visit may be conducted by telephone if discharged

Trial Site Locations

Total: 1 location

1

Saint Louis Hospital

Paris, France, 75010

Actively Recruiting

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Research Team

F

François DEPRET, MD

M

Matthieu LEGRAND, MD-PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Frequently Asked Questions

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Published Research Related To This Trial

The A2B trial, antibiotic prophylaxis for excision-graft surgery in burn patients: a multicenter randomized double-blind study.

François Dépret, Boris Farny, Mathieu Jeanne...

https://pubmed.ncbi.nlm.nih.gov/33239101