NCT07048899Enrolling By Invitation4 期
Effects of Irrisept Irrigation in Emergency General Surgery Cases on SSI Rates
The University of Texas Health Science Center at Tyler1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2024年9月4日最近更新:
干预措施
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Surgical Site Infection Rate
研究概览
简要总结
This is a single institution, randomized study conducted to determine if irrigation with Irrisept in emergency general surgery patients results in lower surgical site infections compared to normal saline irrigation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients (>18 years old at time of enrollment) who are hospitalized at UT Tyler and undergo an open (or conversion to open) wound class 2-4 surgical procedure for an emergent surgical condition.
排除标准
- •Those <18 years of age
- •Pressure wounds
- •Superficial abscesses (as primary diagnosis)
- •intra-abdominal abscess due to previous technical failure
研究组 & 干预措施
Standard of Care (Normal Saline)
Placebo Comparator
Irrigation with Normal Saline
干预措施: Normal Saline (Drug)
Intervention (Irrisept)
Experimental
Irrigation with Irrisept
干预措施: Chlorhexidine (Drug)
结局指标
主要结局
Surgical Site Infection Rate
时间窗: Time of enrollment to 30 days
Determine if the rate of SSI is different
次要结局
- Length of Stay(From date of admission until date of discharge from the hospital, assessed up to 30 days post-operatively)
- Incidence of SSI and surgical wound class with the use of Irrisept(Time of enrollment to 30 days)
- Readmission Rates due to SSI(From day of surgery to 30 days)
研究者
Brittany Wagner
General Surgery Resident
The University of Texas Health Science Center at Tyler
研究点 (1)
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