Chlorhexidine Versus Povidone-iodine Antisepsis for Reduction of Post Cesarean Section Surgical Site Infection Rate:a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 410
- 试验地点
- 1
- 主要终点
- Surgical site infection within one week after surgery
研究概览
简要总结
There is no difference between using chlorhexidine-based antisepsis protocol versus povidone-iodine protocol in reduction of surgical site infection in women undergoing cesarean section.
详细描述
The aim of this study is to examine the efficacy &safety of Chlorhexidine-based antisepsis protocol versus povidone- iodine protocol used as preoperative skin antisepsis for patients undergoing cesarean section in reduction of surgical site infection.Chlorhexidine is a chemical antiseptic. It is effective on both Gram-positive and Gram-negative bacteria, although it is less effective with some Gram-negative bacteria. It has both bactericidal and bacteriostatic mechanisms of action, the mechanism of action being membrane disruption.
Iodine is commonly used as an antiseptic agent clinically. Iodine is usually formulated as an iodophor, which consists of iodine combined with a carrier molecule. This formulation increases the solubility of iodine and provides a reservoir for sustained release. The most commonly used iodophor is povidone iodine which is a 10% iodophor solution that contains 1% available iodine. Iodine molecules penetrate microbial cell walls and cause oxidation of cysteine, iodination of amino acids and unsaturated fatty acids. This leads to reduced protein synthesis and bacterial cell wall damage.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patient 18 years of age or older who will undergo cesarean deliveries who are at term (37wks-41wks of gestation).
- •Body mass index (BMI) between 20-35kg/m
- •Able to communicate well with the investigator and to comply with the requirements of the entire study.
排除标准
- •Rupture of membranes.
- •Patients who have history of allergy to chlorhexidine, alcohol and iodophors.
- •Documented concomitant infections like: Chorioamnionitis, Pyelonephritis, Urinary tract infection, Mastitis.
研究组 & 干预措施
chlorhexidine _based antisepsis
Including cases undergoing elective&non elective caesarean section.Patients will be were prepared similarly by three applications of 2%chlorhexidine solution time given between each application about 30 seconds followed by drying with a sterile towel and three applications of 70% alcohol after one minute The area scrubbed was from the xiphoid to the knee, reaching the midaxillary line laterally. In both groups, patients received preoperative prophylactic i.v antibiotics (cefotrixone 1 gm) one hour before skin incision.
.
干预措施: Chlorhexidine (Drug)
povidone_iodine based antisepsis
Including cases undergoing elective&nonelective caesarean section.Patients will be scrubbed preoperative with an applicator that contain 10%povidone-iodine scrub aqueous solution(3 consecutive applications)followed by drying with sterile towel and 3 application of 70% alcohol after one minute The area scrubbed was from the xiphoid to the knee, reaching the midaxillary line laterally. In both groups, patients received preoperative prophylactic i.v antibiotics (cefotrixone 1 gm) one hour before skin incision
干预措施: Povidone-Iodine (Drug)
结局指标
主要结局
Surgical site infection within one week after surgery
时间窗: One week
次要结局
- Surgical site infection within 30 days after surgery(in 30 days)
- Hospital readmission(30 days)
- Febrile morbidity(10 days)
- Long hospital stay(30 days)
研究者
AMR HELMY YEHIA
MD,MRCOG
Ain Shams Maternity Hospital