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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Incidence of cs Scar Infection

Intervention / Treatment
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* Other: irrigation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 37 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: no irrigation group<br>nothing used for irrigation of cs scar | |
| Placebo Comparator: saline irrigation group<br>saline used for irrigation the cs scar before closure | Other: irrigation<br>* irrigation the edges of the cs scar before closure<br>|
| Experimental: betadine irrigation group<br>betadine used for irrigation of cs scar | Other: irrigation<br>* irrigation the edges of the cs scar before closure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of cs scar infection | incidence of cs scar infection | 2 to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of hematoma, seroma | incidence of hematoma, seroma, wound breakdown | 2 to 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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saline, betadine, cesarean scar infection