2024-514349-13-00
Recruiting
Phase 3
A2B-trial Antibioprophylaxis for excision-graft surgery in burn patient : a multicenter randomized double-bling study
Assistance Publique Hopitaux De Paris10 sites in 1 country506 target enrollmentStarted: August 23, 2024Last updated:
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 506
- Locations
- 10
- Primary Endpoint
- Post-operative infection defined as Post-operative sepsis and/or surgical site infection, and/or autograft lysis requiring a new autograft within 7 days after surgery
Overview
Brief Summary
Evaluate the impact of systemic antibiotic prophylaxis on postoperative infections, sepsis and autograft lysis needing new skin autograft (within 7 days postoperatively) in burn patients.
Study Design
- Allocation
- Randomized
- Primary Purpose
- A2b-trial
- Masking
- Double (Investigator, Monitor, Carer, Subject)
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Major patient over 18 years
- •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
- •known colonization of the burned area to be excised with tazocillin-resistant germ.
- •obese patient with BMI > 50 kg/m²
- •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
Outcomes
Primary Outcomes
Post-operative infection defined as Post-operative sepsis and/or surgical site infection, and/or autograft lysis requiring a new autograft within 7 days after surgery
Post-operative infection defined as Post-operative sepsis and/or surgical site infection, and/or autograft lysis requiring a new autograft within 7 days after surgery
Secondary Outcomes
- - 90 days mortality
- - Skin raft lysis requiring a new autograft procedure
- - Post-operative pulmonary infection
- - Number of days of hospitalization until complete healing (> 95% total burn surface area)
- - Number of hospitalization days living without antibiotic therapy at D28 and D90
- - Multiresistant bacteria (15) colonization of infection at D28 and D90
Investigators
coordinating investigator
Scientific
Assistance Publique Hopitaux De Paris
Study Sites (10)
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