Normal Saline Versus Betadine Use to Reduce the Incidence of Wound Infection in Cesarean
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- incidence of cs scar infection
研究概览
简要总结
This is a prospective randomized controlled study to the difference between using normal saline or betadine irrigation of wound prior to skin closure in reducing the incidence of wound infection after Cesarean section.
详细描述
This study will be conducted at the Department of Obstetrics & Gynecology, Kasr El-Ainy Teaching Hospital, Faculty of Medicine, Cairo University, from February to July 2018.
We include in our study 3oo pregnant women who will undergo Cesarean section. All participants will be divided into 3 groups with a 1:1:1 ratio with 100 patients in each group. Each participant will provide an informed written consent.
Consenting patients will be pre-operatively randomised using numerically ordered cards in sealed envelopes to either the group 1 (wound irrigation with 100 ml of normal saline before skin closure) or the group 2 (wound irrigation with 50 ml of 10% aqueous povidone iodine solution ̋ Betadinȅ ) or the control group (no wound irrigation with normal saline nor betadine).Subjects candidate for the study will be 37 weeks' gestation and require a cesarean section (elective or emergency). Patients with allergy to iodine, history of immunosuppressive drug use, gestationaldiabetes mellitus or preeclampsia, anemic patients, ruptured of membranes and feverish patients will be excluded from the study.
The primary outcome will be the incidence of wound infection. Wound infection is diagnosed when the wound drained purulent material or serosanguineous fluid in association with induration, warmth and tenderness. Suspected wound infections are opened for confirmation and wound cultures will be taken. Haematoma, seroma, or wound breakdown in the absence of the previouslydiscussed signs is not considered a wound infection.Wounds are examined twice daily during hospitalization for evidence of infection. After discharge, the women are instructed on the signs and symptoms of wound infection, and asked to contact one of the co-authors immediately if any of the listed symptoms appeared. All participants are examined at 2 and 6 weeks after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 37 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subjects candidate for the study will be 37 weeks' gestation
- •require a cesarean section (elective or emergency).
排除标准
- •Patients with allergy to iodine
- •history of immunosuppressive drug use,
- •gestationaldiabetes mellitus
- •preeclampsia
- •anemic patients
- •ruptured of membranes
- •feverish patients
研究组 & 干预措施
no irrigation group
nothing used for irrigation of cs scar
saline irrigation group
saline used for irrigation the cs scar before closure
干预措施: irrigation (Other)
betadine irrigation group
betadine used for irrigation of cs scar
干预措施: irrigation (Other)
结局指标
主要结局
incidence of cs scar infection
时间窗: 2 to 6 weeks
incidence of cs scar infection
次要结局
- incidence of hematoma, seroma(2 to 6 weeks)
研究者
hadeer meshal
assistant prfessor
Kasr El Aini Hospital
