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.
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.
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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
Primary outcome measure(s)
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. — 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.
Post-operative sepsis — 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.
Surgical site infection — 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)
Graft lysis needing a new graft procedure — 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.
Trial sites (1)
Facility
City
Region
Status
Saint Louis Hospital
Paris
France
Recruiting
More Assistance Publique - Hôpitaux de Paris trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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