Effect of Surgiphor (sterile Povidone-Iodine) Wound Irrigation on Rate of Positive Deep Culture and NGS in Primary Total Shoulder Arthroplasty- a Prospective, Randomized Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Reduction or elimination of bacteria
研究概览
简要总结
Bacteria is occasionally present in the shoulder during shoulder arthroplasty surgery and is hypothesized to increase the risk of failure of the prosthesis. Surgiphor (sterile Povidone-Iodine) wound irrigation, is a solution used in orthopaedic surgery and other surgical fields to kill bacteria intraoperatively. The Iodine dissociates from complex and has antimicrobial properties, causing cell death of bacteria, fungi, and viruses through interactions with proteins, nucleotides, and fatty acids in the cytoplasm and cytoplasmic membrane.
This study examines the use of Povidone-Iodine during primary shoulder arthroplasty.
详细描述
The purpose of this study is to determine the rate of reduction of positive cultures collected before and after wound irrigation with either Surgiphor or sterile normal saline during primary total shoulder arthroplasty
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
- 是
入选标准
- •Adults age >18 years
- •Participants undergoing elective primary total shoulder arthroplasty
- •Participants willing to provide written consent
排除标准
- •History of prior surgery to the operative shoulder
- •Known allergy to povidone iodine, iodine or shellfish
- •active clinical infection
- •participation in other clinical trials
研究组 & 干预措施
Total Shoulder Arthroplasty washed with Saline
This arm will consist of sterile normal saline to be used before and after placement of shoulder arthroplasty components
干预措施: sterile saline solution (Drug)
Total Shoulder Arthroplasty washed with Saline
This arm will consist of sterile normal saline to be used before and after placement of shoulder arthroplasty components
干预措施: Sample Collection (Procedure)
Total Shoulder Arthroplasty washed with Surgiphor (Povidone Iodine)
This arm will consist of Surgiphor to be used before and after placement of shoulder arthroplasty components
干预措施: Surgiphor (Drug)
Total Shoulder Arthroplasty washed with Surgiphor (Povidone Iodine)
This arm will consist of Surgiphor to be used before and after placement of shoulder arthroplasty components
干预措施: Sample Collection (Procedure)
结局指标
主要结局
Reduction or elimination of bacteria
时间窗: 90 days
To determine the rate of reduction of positive cultures collected before and after wound irrigation with either Surgiphor or sterile normal saline during primary total shoulder arthroplasty participants will be followed to watch for clinical signs of infection.
次要结局
未报告次要终点