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临床试验/NCT04483063
NCT04483063Unknown不适用

Can Additional Preoperative Skin Cleaning on Face, Neck and Chest With Chlorhexidine Reduce Cutibacterium Acnes Contamination on Sutures in Arthroscopy Rotator Cuff Repair?

National Cheng-Kung University Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年3月23日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
90
试验地点
1
主要终点
Culture positive

研究概览

简要总结

The purpose of our study was to investigate whether preoperative skin cleaning on face, neck, and chest with chlorhexidine could reduce suture contamination of C. acnes in arthroscopic rotator cuff repair. We hypothesized that preoperative skin cleaning on face, neck and chest with chlorhexidine can reduce C. acnes contamination on sutures in arthroscopic rotator cuff repair.

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 (Participant)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • primary arthroscopic rotator cuff repair

排除标准

  • younger than 18 years
  • having previous shoulder surgeries or shoulder infection episodes
  • having a history of allergy to chlorhexidine
  • who refused to participate

研究组 & 干预措施

Extended shoulder group

Experimental

2% chlorhexidine gluconate skin cleanser over the not only the operative shoulder and axilla but also the chest, back, neck, and face

干预措施: 2% chlorhexidine gluconate skin cleanser (Drug)

Shoulder group

Experimental

2% chlorhexidine gluconate skin cleanser over the operative shoulder and axilla

干预措施: 2% chlorhexidine gluconate skin cleanser (Drug)

结局指标

主要结局

Culture positive

时间窗: Within 2 weeks postoperatively

Culture positive for C. acnes from the suture used in the arthroscopy

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

Kai-Lan Hsu

Attending physician

National Cheng-Kung University Hospital

研究点 (1)

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