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

Who is this study for? Patients with Burns
What treatments are being studied? Active Intervention
Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
France
Saint Louis Hospital
RECRUITING
Paris
Contact Information
Primary
François DEPRET, MD
francois.depret@aphp.fr
01 42 49 95 70
Backup
Matthieu LEGRAND, MD-PhD
matthieu.m.legrand@gmail.com
01 42 49 95 70
Time Frame
Start Date: 2020-10-11
Estimated Completion Date: 2025-01-09
Participants
Target number of participants: 506
Treatments
Active_comparator: 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.
Placebo_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov