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临床试验/NCT02202577
NCT02202577已完成不适用

Chlorhexidine-Alcohol Versus Povidone-Iodine for Surgical Site Antisepsis Prior to Cesarean Delivery

Case Western Reserve University1 个研究点 分布在 1 个国家目标入组 932 人开始时间: 2014年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
932
试验地点
1
主要终点
Number of Patients With Surgical Site Infection

研究概览

简要总结

Primary Hypothesis: chlorhexidine gluconate alcohol skin antiseptic preparation is superior to povidone-iodine scrub and paint skin antiseptic preparation for prevention of cesarean related surgical site infection.

详细描述

Patients who are considered likely to need cesarean delivery or who are planning cesarean will be recruited and consented for study participation during prenatal care and/or at time of admission to labor and delivery.

Patients undergoing cesarean who meet inclusion/exclusion criteria will be randomized to one of two surgical preparations as listed above (1. Chlorhexidine Gluconate (CHG)-alcohol, or 2. Povidone Iodine (P-I) scrub and paint. Randomization will be performed by the consenting surgeon (listed as key personnel) after the patient has arrived into the operating room for cesarean. Pre-operative surgical site antisepsis will be performed according to randomization. All other surgical practices will remain at the surgeon's discretion according to standard of care at Metrohealth.

Patients will be examined daily by the obstetric team and evaluated for signs and symptoms of surgical site infection, as standard in the investigators institution. The chart will be reviewed to determine if the patient was diagnosed during admission, or, re-admitted because of surgical site infection. The patient will also be questioned regarding any treatment or diagnosis of Surgical Site Infection (SSI) that occured after discharge to home at the routine six week post-operative visit. If patient does not return for the routine post-operative visit, the investigator will attempt to contact the patient by telephone to determine if the patient had been diagnosed or treated for surgical site infection. If patient is lost to 6 week follow up, subanalysis will be performed on available data derived from hospitalization and hospital Electronic Medical Record (EMR).

Data will be captured in RedCAP database.

Additional data will be captured that may affect patient likelihood of surgical site infection to ensure that both groups are statistically equal in risk factors for SSI: labor or rupture of membranes prior to cesarean, maternal age, estimated gestational age, Body Mass Index (BMI), gravity, parity, race, smoking status, hypertensive morbidity, diabetes, estimated blood loss, operative time, race, insurance type, general versus regional anesthesia, appropriate antibiotic prophylaxis given, skin closure (sutures v. staples).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • cesarean delivery
  • age 18-65
  • ability to consent in English or Spanish

排除标准

  • inability or unwillingness to consent to study participation in English or Spanish
  • current incarceration
  • pre-operative diagnosis of chorioamnionitis
  • perceived inability to complete follow up for data collection
  • any prior known allergy or adverse reaction to either study preparation

研究组 & 干预措施

Chlorhexidine - Isopropyl alcohol

Experimental

Pre-operative skin preparation with Chlorhexidine Gluconate- Isopropyl alcohol

干预措施: Chlorhexidine - Isopropyl alcohol (Drug)

Povidone-Iodine Scrub and Paint

Experimental

Pre-operative skin preparation with Povidone-Iodine Scrub and Paint

干预措施: Povidone-Iodine Scrub and Paint (Drug)

结局指标

主要结局

Number of Patients With Surgical Site Infection

时间窗: 4 weeks after cesarean delivery

Number of Patients with Cesarean-Related surgical site infection by Center for Disease Control (CDC) criteria: superficial, deep, organ space.

次要结局

  • Number of Patients With Non-infections Surgical Site Complications(4 weeks after cesarean delivery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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