Skin Preparation of Patients Before Orthopedic Surgery : A Randomized Controlled Study on the Efficacy of Chlorhexidine Cloths Versus Chlorhexidine Soaps
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Relative decrease in the number of bacterial colonies before the antiseptic preparation of the operating site at the surgical room (T1)
研究概览
简要总结
Surgical site infections (SSI) in orthopedic surgery are rare events but associated with great morbidity as well as a significant additional cost. The World Health Organization (WHO) recently carried out meta-analyzes on all the existing prophylactic measures and could not rule on the use of chlorhexidine (CHX) cloths due to the low number of studies available. CHX cloths could actually benefit patients for whom preoperative showering is not possible, whether in emergency or trauma settings due to pain-induced functional impotence. A randomized controlled clinical study aimed at evaluating the in vivo microbiological efficacy of CHX cloths in a population of orthopedic surgery patients while evaluating the psycho-social determinants of adherence to a new preoperative preparation technique seems essential.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients,
- •undergoing orthopedic surgery: programmed hip prosthesis (non-urgent),
- •admitted the day before the operation
- •and having given their written consent.
排除标准
- •presence of a documented infection at the time of the intervention,
- •presence of skin wounds,
- •presence of antibiotic treatment within 15 days before the operation
- •intolerance to CHX,
研究组 & 干预措施
Interventional
Skin preparations (the day before and the morning of the operation) with the 2% CHX cloths
干预措施: 2% CHX cloths (Drug)
结局指标
主要结局
Relative decrease in the number of bacterial colonies before the antiseptic preparation of the operating site at the surgical room (T1)
时间窗: Between the patient's admission to the CHU GA and just before the antiseptic preparation of the operating site at the surgical room (Day 1)
Relative decrease in the number of bacterial colonies measured between the patient's admission to the Grenoble Alps University Hospital (CHU GA) (T0) and after 2 preoperative skin preparations (the day before and the morning of the operation), and just before the antiseptic preparation of the operating site at the surgical room (T1) in the 2% CHX cloths group versus the 4% CHX soap group.
次要结局
- Relative decrease in the number of bacterial colonies after 1 preoperative skin preparation(Between the patient's admission to the CHU GA and after 1 preoperative skin preparation (Day 0))
- Relative decrease in the number of bacterial colonies after 2 preoperative skin preparations(Between the patient's admission to the CHU GA and after 2 preoperative skin preparations (Day 1))
- Nursing load(Between the patient's admission to the CHU GA and just before the antiseptic preparation of the operating site at the surgical room (Day 1))
- Significant predictors of a decrease in bacterial colonization(Between the patient's admission to the CHU GA and just before the antiseptic preparation of the operating site at the surgical room (Day 1))
- Percentage of skin adverse reactions(Between the patient's admission to the CHU GA and just before the antiseptic preparation of the operating site at the surgical room (Day 1))
- Duration of preoperative skin preparation(Between the patient's admission to the CHU GA and just before the antiseptic preparation of the operating site at the surgical room (Day 1))
- Responses to a questionnaire for patients and adherence score(Between surgery and discharge from the hospital (Day 4))
- Responses to a semi-structured interview intended for healthcare professionals(Interview at the end of the inclusion of patients (through study completion, an average of 6 months))