Comparison of Surgical Skin Preps During Cesarean Deliveries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,404
- 试验地点
- 2
- 主要终点
- Cesarean Surgical Site Infection
研究概览
简要总结
In women that undergo non-emergency cesarean delivery, we are comparing the skin preparation solutions for best outcome of surgical site infection. The three different solutions are: Group 1: Iodine povidone based skin preparation solution. Group 2: Chlorhexidine based skin preparation solution or Group 3: Combination usage of iodine povidone and chlorhexidine based skin preparation solutions. Women are prospectively randomized to one of the three groups and followed until thier postpartum visit at 6-8 weeks following delivery.
详细描述
Currently the skin preparation solutions currently in use for cesarean delivery are chlorhexidine-alcohol based solutions or iodine povidone solutions There had been no recommendations of which surgical skin prep wound be best utilized for cesarean delivery, especially if the patient has risk factors for surgical site infection. Chlorhexidine solution has been reported to take minimal of 2 minutes after application to decrease the bacterial load, and continue to decrease the bacteria load up to 1 hour. Iodine povidone solution has been reported to be completely effective within 4 minutes of application. Patient's risk factor for surgical site infection, including obesity, history of incision complications, maternal diabetes, chorioamnionitis, potentially influence which surgical skin prep to be applied. Finally, the majority of postpartum infections manifest after hospital discharge and most of these post-discharge infections are diagnosed and treated entirely in the ambulatory setting, without the patients' returning to the hospital.
The purpose of the study is:
- To compare chlorhexidine based solution, iodine povidone solution, and combination of both agents in cesarean delivery skin preparation solution for prevention of surgical site infection (SSI)
- To determine if surgical site infection (SSI) risk factors should guide selection of one specific surgical skin preparation solution.
This will be a prospective randomized observational study of the women presenting for care to the Montefiore Medical Center. All patients will undergo routine obstetrical care and preparation for cesarean delivery as if they were not participating in this research study. All patients in the study will receive the pre-operative intravenous antibiotics pre-operatively as part of departmental protocol for cesarean delivery.
The patients will be randomized after informed consent obtained into one of three groups: Group 1: Iodine povidone based skin preparation solution. Group 2: Chlorhexidine based skin preparation solution or Group 3: Combination usage of iodine povidone and chlorhexidine based skin preparation solutions. Sequentially numbered envelopes will contain the group of randomization for the patient created by a computer generated program which will occur prior to commencement of the study.
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 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gestational age > 37 weeks 0/7 days
- •Non-emergency indication for cesarean
排除标准
- •Urogenital tract infection within 2 weeks prior to surgery
- •Chronic oral or injectable steroid use (> 2 weeks)
- •Emergency cesarean delivery
- •Participation in another research study
研究组 & 干预措施
Combination iodine and chlorhexidine
The combincation skin preparation will utilize the iodine based preparation first followed by the chlorhexidine based skin preparation prior to cesarean delivery.
干预措施: Combination iodine and chlorhexidine (Drug)
Chlorhexidine
Chlorhexidine based skin preparation solution applied to skin prior to cesarean delivery
干预措施: Chlorhexidine (Drug)
Iodine povidone
Iodine povidone based skin preparation solution applied to skin prior to cesarean delivery
干预措施: Iodine povidone (Drug)
结局指标
主要结局
Cesarean Surgical Site Infection
时间窗: 42 days after delivery
Surgical site infection will follow CDC guidelines: A) Superficial incisional surgical site infection B) Deep incisional surgical site infection or C) Organ/space surgical site infection.
次要结局
未报告次要终点
研究者
David Garry
Co-Director Obstetrics & MFM service Wakefield Division
Montefiore Medical Center
