2024-515146-16-00招募中3 期
PROPHYLOXITIN-Intermittent cefoxitin administration versus loading bolus followed by continuous infusion for the prevention of surgical site infection in colorectal surgery: a multicentre, double-blind, randomized controlled clinical trial
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 18
- 主要终点
- Proportion of patients with any SSI within 30 days after surgery.
研究概览
简要总结
The main objective is to demonstrate the superiority of a loading dose of cefoxitin followed by continuous infusion over standard of care boluses in reducing SSI within 30 days after colorectal surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Randomization
- 盲法
- Double (Investigator, Subject)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Adult patients (≥18 years)
- •Undergoing colorectal surgery (predictable duration > 90 min)
- •Patients benefiting from a Social Security system or benefiting from it through a third party
- •Free subject, without guardianship or curatorship or subordination
- •Having given their informed consent
排除标准
- •Patients with known history of hypersensitivity to cefoxitin or others beta-lactams
- •Patients with extreme severe obesity (defined by a body mass index greater than 50 kg/m2)
- •Patients with severe renal insufficiency (clearance creatinine < 30ml/min)
- •Active bacterial infection at the time of surgery or recent antimicrobial therapy (up to 2 weeks before surgery) except for oral surgical antibiotic prophylaxis
- •Participation to another clinical trial aimed at reducing SSI
- •Patients already previously enrolled in this study
- •Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception (hormonal/mechanical: per os, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total ovariectomy)
- •Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, adults under legal protection
结局指标
主要结局
Proportion of patients with any SSI within 30 days after surgery.
Proportion of patients with any SSI within 30 days after surgery.
次要结局
- Proportion of patients with each type of SSI (superficial, deep and/or organ–space infection)
- Proportion of patients with surgical reintervention
- Proportion of patients with anastomotic leak
- Proportion of patients with postoperative complication according to the Dindo and Clavien classification
- Proportion of patients with Clostridium difficile infection
- Hospital readmission censored at day 30
- Unexpected admission to the ICU censored at day 30
- Duration of hospital stay and hospital free days
- All-causes mortality
- Proportion of per operative adverse events
研究者
Pr Matthieu BOISSON
Scientific
Centre Hospitalier Universitaire De Poitiers
研究点 (18)
Loading locations...
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