A Randomized Control Trial of Chlorhexidine Gluconate Aqueous Solution vs Chlorhexidine Gluconate With Isopropyl Alcohol Skin Preparations for Prevention of Cesarean Section Wound Infections
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,398
- 试验地点
- 1
- 主要终点
- Number of Participants with Surgical site Infection
研究概览
简要总结
This will be a single-center randomized control trial comparing the efficacy of two different formulations of Chlorhexidine surgical skin preparation in preventing cesarean section wound infections. Participants will be randomized to either 4% Chlorhexidine Gluconate aqueous solution (CHG) or 2% Chlorhexidine with isopropyl alcohol (CHG-IPA) 70% to examine the risk of infectious morbidity in those undergoing cesarean delivery. There will also be a cost-effectiveness analysis of the two preoperative skin preparations.
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 (Outcomes Assessor)
盲法说明
The provider making the diagnosis of wound infection will be blinded to the intervention
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women undergoing cesarean delivery at Magee Women's Hospital
排除标准
- •Inability to obtain consent (language barrier, emergency cesarean section etc.)
- •Allergy to chlorhexidine or alcohol
- •Chorioamnionitis
- •Emergency cesareans where cannot wait for chlorhexidine alcohol to dry
- •bowel injury at time of cesarean section
- •Women who are delivered at another institution and are transferred postpartum to Magees Women's Hospital
研究组 & 干预措施
2% Chlorhexidine gluconate with 70% alcohol (ChloraPrep)
Including cases undergoing elective &non elective caesarean section. Patients will be prepared similarly using the appropriate number of 26mL Chloraprep sticks for their body surface area. The lever will be pinched to activate the ampoule and release the antiseptic. The solution will be given time to partially load in the sponge. The sponge will be pressed against the skin area where the incision is intended moving back and forth for 30 sec , then working up towards the upper edge of the surgical field and then working from below the incision sight to the upper thighs. The antiseptic will be given time to dry (3 min)
干预措施: 2% Chlorhexidine gluconate with 70% alcohol (Drug)
4% chlorhexidine gluconate (Hibiclens)
Including cases undergoing elective & nonelective caesarean section. Patients will be scrubbed preoperative with an applicator that contain 4% chlorohexidine aqueous solution (3 consecutive applications) liberally over 2 minutes followed by drying with sterile towel. The area scrubbed will be the same as the chloraprep group.
干预措施: 4% Chlorhexidine Gluconate aqueous solution (Drug)
结局指标
主要结局
Number of Participants with Surgical site Infection
时间窗: Within 30 days post cesarean
Superficial or deep surgical-site infection within 30 days after cesarean delivery, on the basis of the National Healthcare Safety Network definitions of the Centers for Disease Control and Prevention.
次要结局
- Number of participants with hematoma(Within 90 days post cesarean)
- The type of bacterial species isolated from wound infection cultures(Within 90 days post cesarean)
- Length of Hospital Stay(Within 90 days post cesarean)
- Number of Participants who needed wound vacuum(Within 90 days post cesarean)
- Number of Participants who needed home health(Within 90 days post cesarean)
- Number of doses of antibiotic treatment(Within 90 days post cesarean)
- Number of participants with positive culture from wound(Within 90 days post cesarean)
- Number of Participants with intrabdominal/pelvic abscess(Within 90 days post cesarean)
- Number of Participants With Endometritis(Within 30 days post cesarean)
- Number of Participants with necrotizing fasciitis(Within 90 days post cesarean)
- Number of Participants with sepsis(Within 90 days post cesarean)
- Number of Participants with Need for wound opening, exploration, or washout in the operating room(Within 90 days post cesarean)
- Number of Participants With Re-admissions or Office Visits for Wound-related Problems(Within 90 days post cesarean)
- Number of Participants with ICU admission for wound infectious complications(Within 90 days post cesarean)
- Number of patients who needed antibiotics(Within 90 days post cesarean)
- Antibiotic regimens (medication names) used to treat infection(Within 90 days post cesarean)
- Number of participants with seroma(Within 30 days post cesarean)
- Number of Participants With Skin Irritation(within 48 hours from delivery)
- Number of Participants With Allergic Reaction(within 48 hours from delivery)
- Cost Savings(Within 90 days post cesarean)
研究者
Hyagriv Simhan
Professor
University of Pittsburgh