跳至主要内容
临床试验/NCT07239349
NCT07239349招募中不适用

Investigating Whether Preoperative Use of Acne Face Wash for Cleansing the Face, Neck, and Chest Helps Reduce the Contamination Rate of Cutibacterium Acnes in Arthroscopic Rotator Cuff Repair Surgery

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年11月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
1
主要终点
Suture culture results

研究概览

简要总结

Previous studies have shown that even when following standard sterilization protocols, the positive culture rate of Cutibacterium acnes can still be as high as 30%. In recent years, several studies have reported that preoperative skin preparation of the shoulder, such as applying benzoyl peroxide (BPO) to the skin, can effectively reduce the cutaneous bacterial load of C. acnes and even decrease its incidence in the shoulder joint or surgical sutures after surgery. However, most of the existing studies have focused on arthroplasty, and robust evidence regarding contamination in rotator cuff surgery remains lacking. Therefore, this study aims to investigate whether preoperative skin preparation with a 10% BPO acne cleanser can effectively reduce contamination in rotator cuff surgery. The findings will help guide future clinical practice in preoperative preparation. This study will adopt a prospective randomized design. Patients will be randomly assigned (using a random number table) into two groups: the control group and the BPO cleanser group. All patients will receive instructions on preoperative skin cleansing. Patients in the control group will follow the current routine practice in our institution, cleansing the surgical site (shoulder) with soap or body wash. Patients in the BPO group, in addition to routine preoperative instructions, will receive specific guidance on cleansing the shoulder and surrounding skin. They will be provided with a 10% BPO acne cleanser and instructed to use it on the shoulder and surrounding area during bathing the day before surgery. After surgical disinfection, skin samples will be collected for bacterial culture. In addition, a segment of surgical suture will be obtained postoperatively for bacterial culture.

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
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

  • •rotator cuff tear
  • •scheduled for arthroscopic rotator cuff repair surgery

排除标准

  • •history of shoulder fracture
  • •previous shoulder surgeries
  • •tatoo on the shoulder

研究组 & 干预措施

Control

No Intervention

Use soap to wash shoulder before surgery

Acne face wash

Experimental

Use acne face wash to clean shoulder before surgery

干预措施: Acne face wash (Other)

结局指标

主要结局

Suture culture results

时间窗: Right after the surgery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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