Does Disinfection of the Subcutaneous Tissue Reduce Contamination of the Operating Field With P. Acnes Compared to Dissection With an Electric Cautery During Primary Shoulder Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- positive sample
研究概览
简要总结
Propionibacterium acnes is a pathogen commonly identified in postoperative shoulder infections. A recent study has shown that P. acnes is likely to be disseminated in the operating field from the subcutaneous layer by the manipulation of soft tissues by the surgeon and the instruments. Disinfection of the subcutaneous tissue seems to significantly reduce contamination of the operating field during primary shoulder surgery. This study seeks to assess the efficacy of disinfection of the subcutaneous tissue compared to dissection with an electrosurgical unit on P. acnes contamination during primary shoulder surgery.
详细描述
The investigators are going to study the efficacy of disinfecting the subcutaneous tissue with Betadine standard solution during primary shoulder surgery compared to electrosurgical dissection. They will randomize 105 patients on two arms. The control group receiving no disinfection of the subcutaneous tissue but a dissection with an electric cautery(A) and intervention group receiving a disinfection of the subcutaneous tissue (B). They believe that the duration of 4 years is sufficient to recruit the number of patients necessary for this study.
All patients 18 years of age or older admitted to Valais Hospital for primary shoulder surgery and having signed the consent of the study will be eligible.
The use of disinfection of the subcutaneous tissue during primary shoulder surgery could reduce contamination of the operating field and theoretically the post-operative infection rate after primary shoulder surgery.
The study focuses on disinfection with Betadine solution of the subcutaneous tissue during primary shoulder surgery. This action could decrease contamination of the operating field and the infection rate after primary shoulder surgery.
This solution is already widely used for disinfecting the skin and traumatic or surgical wounds.
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, Outcomes Assessor)
盲法说明
A standard block randomization strategy will be used. The ratio between intervention and control will be set at 2: 1. This will facilitate recruitment and provide more information on the effectiveness of the intervention. The randomization sequence will be created using the STATA program.
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
- •= or> 18 years old
- •treated at the Valais Hospital for primary shoulder surgery.
- •have signed the consent
排除标准
- •<18 years old
- •History of shoulder surgery
- •History of shoulder infection
- •Antibiotic therapy in the 2 weeks preceding the intervention
- •Cortisone infiltration in the 6 months preceding the intervention
- •Allergy to iodinated contrast agent or Cefuroxime
- •Allergy to povidone iodine complex or other contraadication to Betadine
- •Refusal of study terms
结局指标
主要结局
positive sample
时间窗: 4 years
Compare the positive bacteriological sample rate during an open shoulder surgery procedure with a disinfection of the subcutaneous tissue compared to an operating procedure without disinfection but dissection with an electric knife.
次要结局
未报告次要终点