The Efficacy of Swabbing of Subcutaneous Tissues of Cesarean Section Wounds With Povidone Iodine to Prevent Postoperative Wound Infection: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 538
- 主要终点
- Detect and record the incidence of surgical wound infection in both groups
研究概览
简要总结
The study has 2 groups. Group A in which the subcutaneous tissue will be swabbed with 10 cc of undiluted 10% povidone iodine and will not be mobbed. Group B ; No swabbing. Women in both groups will be followed up during hospital stay and outpatient clinic visits a week and a month after cesarean delivery for surgical site complications which will be evaluated by the researcher.
详细描述
Aim of the study:
To assess the efficacy of subcutaneous swabbing of cesarean section wounds with povidone iodine to prevent postoperative wound infection.
Study Design: Randomized controlled trial.
Subjects: Women having a cesarean delivery.
The women will have a full description of the study and Subjects will be randomized by selecting a sequentially numbered sealed envelope to one of each group which will be opened during closure of rectus sheath.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All women having either first time or repeat cesarean section whether elective or emergency.
排除标准
- •Women with prolonged rupture of membranes more than 12 hours.
- •Women with morbid obesity with BMI>
- •Women with diabetes, hypertension or anemia with hemoglobin<
- •Women on corticosteroid therapy or immunosuppressed women.
- •Women with intraoperative hemorrhage or hematoma formation.
- •Women allergic to betadine.
- •The cesarean section which duration exceed one hour or associated with other surgical procedure.
研究组 & 干预措施
Betadine group
Subcutaneous tissues of cesarean section wounds are swabbed with10% undiluted Povidone Iodine solution without mobbing before closure of subcutaneous tissues
干预措施: Povidone iodine (Drug)
结局指标
主要结局
Detect and record the incidence of surgical wound infection in both groups
时间窗: One month
: Women in both groups will be followed up during hospital stay and outpatient clinic visit for one month after cesarean delivery for surgical site complications which will be evaluated by the researcher
次要结局
未报告次要终点
研究者
Essam Rashad Abdel-Hafeez Othman
Associate professor, OB-GYN department- Principal investigator
Assiut University