"Antibioprophylaxis for Excision-graft Surgery in Burn Patient: a Multicenter Randomized Double-blind Study: A2B Trial"
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 506
- 试验地点
- 1
- 主要终点
- Surgical site infection
研究概览
简要总结
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.
详细描述
The intensive care unit investigator will verify the inclusion and non-inclusion criteria.
The following parameters will be collected at ICU/burn centers: Hemodynamic parameters; sepsis organ failure assessment (SOFA) score, Glasgow Coma scale; Medical history / comorbidities; Concomitant treatment; Burn wound bacterial colonization; Biological parameters.
The inclusion and randomization will be performed as late as possible before the first surgical procedure.
Randomization: Burn patients with deep burn between 5 to 40% TBSA requiring at least one excision surgery graft will be randomized to receive antibioprophylaxis (or placebo) 30 minutes before the incision with either first generation cephalosporin (cefazolin) (if absence of colonization to Pseudomonas aeruginosa); or piperacillin-tazobactam (if the burned area is colonized with Pseudomonas aeruginosa). We chose to target specifically Pseudomonas aeruginosa because it has been associated with significant morbidity and risk of graft lysis in burn patients.
No specific exams are required during the 7 days, 28 days and 90 days follow up visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Treatments will be conditioned by the Contract manufacturing organization (central pharmacy of Assistance-Publique Hôpitaux de Paris) according to a list provided by an independent person and assigning a treatment arm to each treatment number
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: active intervention (Drug)
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.
干预措施: placebo intervention (Other)
结局指标
主要结局
Surgical site infection
时间窗: 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
时间窗: 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.
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.
时间窗: 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
时间窗: 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.
次要结局
- Post-operative surgical site infection(7 days after surgery)
- Number of days of hospitalization until complete healing (> 95% total burn surface area)(at Day 28 and Day 90)
- Mortality(At day 90)
- Postoperative bacteremia(within 7 days of surgery)
- Number of hospitalization days living without antibiotic therapy(at Day 28 and Day 90)
- Skin graft lysis requiring a new graft procedure(7 days after surgery)
- Post-operative pulmonary infection(7 days after surgery)
- Number of patients with a colonization with a multidrug resistant bacteria.(at Day 28 and Day 90)