Comparative Study of a Iodine + Cyanoacrylate (Integuseal) vs. Iodine and Isopropyl Alcohol in Skin Preparation for Prevention of Surgical Site Infections in Oncologic Surgery
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 1,200
- 试验地点
- 2
- 主要终点
- Surgical site infection
研究概览
简要总结
The purpose if this study is to determine whether a microbial sealant (iodine + cyanoacrylate) [InteguSEAL®, Kimberly-Clark] reduces surgical site infections when compared to iodine and isopropyl alcohol (povacrylex in isopropyl alcohol) [Duraprep®] in oncologic surgery.
详细描述
Patient's skin flora is a major source of pathogens, and microbial contamination of the surgical site is a likely precursor of SSI. A variety of skin products may be used, including iodophors, alcohol-containing products, and clorhexidine gluconate. Despite these perioperative tactics, bacteria continue to survive at the skin level and migrate to contaminate the wound.
A microbial sealant (InteguSEAL®, Kimberly-Clark) that uses cyanoacrylate to seal endogenous skin flora has demonstrated to reduce wound contamination. The efficacy of the microbial sealant in preventing SSI has been tested in cardiovascular surgery and open inguinal hernia repair, with a reduction on SSI rate when compared to standard skin preparations. This cyanoacrylate has not been tested in oncologic surgeries.
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
- 否
入选标准
- •Patients >= 18 years undergoing elective clean or clean-contaminated breast, gynecologic or digestive tract surgery
- •Accepts to participate and signs the informed consent form
- •Have a telephone number to be contacted after surgery
排除标准
- •Previous allergy to one of the study products
- •Two or more procedures in different anatomical sites at the same time / surgery (v.g. hysterectomy and mastectomy)
- •Pregnancy
- •Breast feeding
- •Contaminated or infected surgeries
结局指标
主要结局
Surgical site infection
时间窗: 30-45 days
Patients we'll be followed prospectively by direct observation to evaluate if a surgical infection occurs. After 30 days of follow-up, patients will be classified as having or not a surgical site infection using the CDC criteria.
次要结局
- Cost analysis(30-45 days)