Can Benzoyl Peroxide Decrease the Burden of Cutibacterium Acnes in Primary Spine and Shoulder Surgery? Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 主要终点
- Cutibacterium acnes
研究概览
简要总结
Obtain deep tissue samples from patients undergoing primary prosthetic surgery of the shoulder and patients undergoing primary instrumented surgery of the spine. Patients will be randomized to receive benzoyl peroxide 3 days prior to surgery.
详细描述
Shoulder prosthetic surgery as well as interventional surgery on the spine are commonly contaminated by Cutibacterium Acnes. Although the significance of this contamination is unknown, it represents a cause for concern since in some patients, contaminating Cutibacterium Acnes from surgery may develop long-term infection of the implant. Unlike knee and hip surgeries, where the most common infection-causing germs are Staphylococcus aureus, in shoulder and spine surgery, Cutibacterium Acnes represents one of the germs most frequently associated with infections. peri implant. Skin preparation with chlorhexidine as well as antibiotic prophylaxis with cefazolin have been shown to be ineffective in eradicating Cutibacterium Acnes. Recently, different studies support the use of benzoyl peroxide in topical application, to reduce the load of Cutibacterium acnes on the skin. Despite this, it has not been shown to reduce the rate of infection, nor to reduce the phylotypes of Cutibacterium acnes associated with peri-implant infections (IA, IB and II).
Obtain deep tissue samples from patients undergoing primary prosthetic surgery of the shoulder and patients undergoing primary instrumented surgery of the spine. Patients will be randomized to receive benzoyl peroxide 3 days prior to surgery.
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)
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
- •patients > 18 yrs.
- •Primary prosthetic shoulder surgery.
- •Instrumented primary surgery of the spine.
排除标准
- •active infection.
- •previous surgeries.
- •interventionism prior to surgery in the last 6 months (infiltrations, arthro-CT, arthro-MRI)
研究组 & 干预措施
Patients without Benzoyl peroxide
干预措施: Benzoyl peroxide (Drug)
Patients with Benzoyl peroxide
干预措施: Benzoyl peroxide (Drug)
结局指标
主要结局
Cutibacterium acnes
时间窗: 2 weeks
isolation of Cutibacterium acnes in the deep tissues
次要结局
未报告次要终点
研究者
Carlos Torrens
Clinical Professor
Hospital del Mar
