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临床试验/NCT05355844
NCT05355844Unknown不适用

Can Benzoyl Peroxide Decrease the Burden of Cutibacterium Acnes in Primary Spine and Shoulder Surgery? Prospective Randomized Study

Hospital del Mar0 个研究点目标入组 200 人开始时间: 2022年5月最近更新:
适应症
干预措施
相关药物

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

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

Sham Comparator

干预措施: Benzoyl peroxide (Drug)

Patients with Benzoyl peroxide

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carlos Torrens

Clinical Professor

Hospital del Mar

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