2024-514349-13-00招募中3 期
A2B-trial Antibioprophylaxis for excision-graft surgery in burn patient : a multicenter randomized double-bling study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 506
- 试验地点
- 10
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 分配方式
- Randomized
- 主要目的
- A2b-trial
- 盲法
- Double (Investigator, Monitor, Carer, Subject)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
- •Patient under guardianship or curatorship
结局指标
主要结局
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
次要结局
- - 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
研究者
coordinating investigator
Scientific
Assistance Publique Hopitaux De Paris
研究点 (10)
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