NCT07721415Enrolling By Invitation4 期
Effect of Iodine Impregnated Drapes on the Rate of Positive Cultures in Primary Total Shoulder Arthroplasty - a Prospective, Randomized Study
tnicholson1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2026年1月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Culture positivity rate
研究概览
简要总结
This study will directly compare the positive culture rate in shoulder arthroplasty using iodine-impregnated versus non-iodine-impregnated drapes used during 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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Adults ≥ 18 years
- •Written informed consent
- •Elective primary total shoulder arthroplasty
- •Male patients
排除标准
- •Prior surgery on the operative shoulder
- •Iodine allergy
- •Participation in other clinical trials
- •Active infection
结局指标
主要结局
Culture positivity rate
时间窗: 13 days
One deep tissue swab will be taken after final implant placement and sent for culture to see if bacteria grows after surgery.
次要结局
未报告次要终点
研究者
tnicholson
Director of Clinical Trials
Rothman Institute Orthopaedics
研究点 (1)
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