A Randomized, Controlled Clinical Trial Evaluating A Novel Perioperative Patient Skin Antiseptic Preparation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Surgical Site Infection Occurrence
研究概览
简要总结
This study will evaluate a new topical skin antiseptic perioperative preparation and the standard of care to determine efficacy on the rates of surgical site infections of surgical patients. Safety will also be assessed.
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
- •Be male or female and at least 18 years of age.
- •Be able to verbalize an understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English.
- •Be planning to undergo clean (class I wound) or clean-contaminated (class II wounds) surgery.
- •Expect to be available for up to 30-days after the surgery.
排除标准
- •Active infection or fever including evidence of infection at or adjacent to the operative site.
- •Immunosuppressed.
- •Kidney/liver failure.
- •Immunosuppressive therapy (chemotherapy, steroids) within the previous 1 week.
- •Any history of allergy to chlorhexidine or isopropyl alcohol or any other component in ZuraGard including citric acid, sodium citrate, methylparaben, or propylparaben, and FD&C Yellow #6.
研究组 & 干预措施
70% Isopropyl Alcohol novel preoperative skin antiseptic
70% v/v Isopropyl Alcohol novel preoperative skin antisepsis preparation
干预措施: 70% v/v Isopropyl Alcohol Surgical Solution (Drug)
2% Chlorhexidine Gluconate/70% Isopropyl Alcohol preoperative skin antiseptic
2% Chlorhexidine Gluconate/70% Isopropyl Alcohol preoperative skin antisepsis preparation
干预措施: 2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol (Drug)
结局指标
主要结局
Surgical Site Infection Occurrence
时间窗: Within 30 days after surgery
The primary objective is to demonstrate efficacy in surgical use through the rate of surgical site infections.
Allergic Reaction and Skin Irritation
时间窗: Within 30 days after surgery
The primary safety objective is to determine the rates of skin irritation or allergic reactions attributed to each drug product and all other adverse events.
次要结局
- Subgroup Analysis of Rates of Surgical Site Infections(Within 30 days after surgery)