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

Phase 2

• Conditions: Incidence of cs Scar Infection
• Interventions: Other: irrigation

• Registration Number: NCT03725748
• Lead Sponsor: Kasr El Aini Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2018-10
• Study First Submitted: 2018-10-20
• Study First Submitted QC: 2018-10-29
• Last Update Submitted: 2018-10-29
• Study First Posted: 2018-10-31
• Last Update Posted: 2018-10-31
• Study Start: 2018-11-01
• Primary Completion: 2019-05
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• Subjects candidate for the study will be 37 weeks' gestation
• require a cesarean section (elective or emergency).

Exclusion Criteria

• Patients with allergy to iodine
• history of immunosuppressive drug use,
• gestationaldiabetes mellitus
• preeclampsia
• anemic patients
• ruptured of membranes
• feverish patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
betadine irrigation group	irrigation	betadine used for irrigation of cs scar
saline irrigation group	irrigation	saline used for irrigation the cs scar before closure

Primary Outcome Measures

Name	Time	Method
incidence of cs scar infection	2 to 6 weeks	incidence of cs scar infection

Secondary Outcome Measures

Name	Time	Method
incidence of hematoma, seroma	2 to 6 weeks	incidence of hematoma, seroma, wound breakdown

Trial Locations

Locations (1)

Kasr El Ainy; 🇪🇬 Cairo, Egypt