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临床试验/NCT03725748
NCT03725748Unknown2 期

Normal Saline Versus Betadine Use to Reduce the Incidence of Wound Infection in Cesarean

Kasr El Aini Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2018年11月1日最近更新:
适应症
干预措施

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

No Intervention

nothing used for irrigation of cs scar

saline irrigation group

Placebo Comparator

saline used for irrigation the cs scar before closure

干预措施: irrigation (Other)

betadine irrigation group

Experimental

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

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

hadeer meshal

assistant prfessor

Kasr El Aini Hospital

研究点 (1)

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