Triple Prevention Against Cutibacterium Acnes Using Benzoyl Peroxide Preparation in Addition to Pre-operative Cutaneous and Subcutaneous Iodine in Shoulder Surgery; a Single-blinded, Randomized, Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Cutibacterium Acnes positivity
研究概览
简要总结
Patients planned for shoulder surgery will be identified and contacted for participation. After informed consent is provided, patients will be randomised into one of three groups: pre-operative cutaneous disinfection with iodine (control group), pre-operative cutaneous and subcutaneous disinfection with iodine (double prevention), and pre-operative cutaneous and subcutaneous disinfection with iodine combined with a skin preparation protocol with benzoyl peroxide gel in the days prior to surgery (triple prevention). Bacterial cultures will be collected during surgery of the surgical field and tissue layers. Culture positivity for Cutibacterium Acnes will be compared between the groups as a primary outcome.
详细描述
Eligible patients will be contacted for participation (see Eligibility Criteria). If subjects meet the inclusion criteria, patients will receive information regarding the study outline, associated risks, and subject rights. Informed consent must be freely given, specific, unambiguous, and may be withdrawn at any time. Subjects must be legally capable of providing consent. Consent will be and recorded in writing and stored for the duration of the study. The target for inclusion was set at 52 patients in each group, of each group 26 will be arthroscopic and 26 open surgery.
Patients will be divided into three groups of equal size:
- Triple-prevention: Benzoyl peroxide at home, subcutaneous iodine, and cutaneous iodine.
- Double-prevention: Cutaneous and subcutaneous iodine.
- Single-prevention (control group): cutaneous iodine.
Simple block randomisation will be used to prevent chronological bias and ensure equal group size. Treatments will be allocated with a 1:1:1 ratio using a block size of 12. Randomisation will be stratified by open or arthroscopic surgery to ensure an equal number in all three groups (3x2x26 patients) Random treatment allocation numbers will be generated and blinded, to be revealed after inclusion.
Benzoyl peroxide:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Since the disinfection protocol has to be performed by the patient and care provider, this can not be blinded. However, the laboratory staff will not know which treatment arm the patient was allocated to when assessing the bacterial cultures.
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
- •Indication for all types of surgery at the shoulder joint, acromioclavicular joint, or clavicle, including arthroscopic and open surgery.
排除标准
- •Previous shoulder surgery;
- •History of shoulder infection;
- •Antibiotic treatment in the last 6 weeks;
- •Allergy or hypersensitivity to one of the disinfecting agents;
- •Patients with laboratory values consistent with a current infection (C-reactive protein, erythrocyte sedimentation rate, leukocyte count).
结局指标
主要结局
Cutibacterium Acnes positivity
时间窗: 14 days
Rate of culture positivity for Cutibacterium Acnes of swabs taken during surgery
次要结局
- Culture positivity with other bacteria(14 days)
- Adherence to pre-operative protocol(1 day)