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临床试验/NCT04308798
NCT04308798Unknown3 期

Comparison of Surgical Glove Contamination During Total Knee Arthroplasty Procedure

Khon Kaen University2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2020年7月最近更新:
适应症

试验速览

阶段
3 期
入组人数
41
试验地点
2
主要终点
comparison contamination rate on surgical glove

研究概览

简要总结

Total knee arthroplasty post-op surgical site infection rate about 0.5- 5% Pre-operative , perioperative and post-operative prevention are importance for reduce surgical site infection The prevention of surgical-site infections (SSIs) is an integral component of nosocomial infection control and a major priority in orthopedic surgery.

Surgical wound contamination must be prevented to avoid patient colonisation by microorganisms during surgery.

Surgical glove changing perioperative can reduce contamination and perforation rate Orthopedic surgery had found contamination rate about 20-28 % Joint replacement procedure found contamination rate about 38-67% of all orthopedic surgery 12% of gloves are contaminated after draping and 24% once patient installation is complete.

We hypothesis that changing surgical glove during total knee arthroplasty can reduce contamination rate on surgical glove.

详细描述

Total knee arthroplasty post-op surgical site infection rate about 0.5- 5% Pre-operative , perioperative and post-operative prevention are importance for reduce surgical site infection The prevention of surgical-site infections (SSIs) is an integral component of nosocomial infection control and a major priority in orthopedic surgery.

Surgical wound contamination must be prevented to avoid patient colonisation by microorganisms during surgery.

Surgical glove changing perioperative can reduce contamination and perforation rate Orthopedic surgery had found contamination rate about 20-28 % Joint replacement procedure found contamination rate about 38-67% of all orthopedic surgery 12% of gloves are contaminated after draping and 24% once patient installation is complete.

Research question : Does changing surgical glove during total knee arthroplasty can reduce contamination rate on surgical glove?

Population : Patient who schedule for primary total knee arthroplasty in Srinagarind hospital

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
Double (Participant, Outcomes Assessor)

盲法说明

Patient and outcome assessor will be blind

入排标准

性别
All
接受健康志愿者

入选标准

  • Patient who schedule for primary total knee arthroplasty

排除标准

  • Patient who had previous history of open knee surgery Patient who have remote infection during period of total knee arthroplasty Patient who have infection around lower extremity at the same site of total knee arthroplasty

结局指标

主要结局

comparison contamination rate on surgical glove

时间窗: 30 months from randomization

Contamination rate on surgical glove during total knee arthroplasty

次要结局

  • Contamination rate on surgical glove(30 months from randomization)

研究者

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

Weerachai Kosuwon

professor

Khon Kaen University

研究点 (2)

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