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

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

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.

Study Overview

• Status: Unknown
• Conditions: Incidence of cs Scar Infection
• Intervention / Treatment: Other: irrigation

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 Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: hany saad, assistant prof; Phone Number: 01001817211; Email: dr_hanysaad@yahoo.co.uk
• Study Contact Backup: Name: ashraf saad, lecturer; Phone Number: 01001817221; Email: ashraf@yahoo.co.uk

Study Locations

• Egypt
  • Cairo, Egypt, 02
    • Kasr El Ainy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 37 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: no irrigation group; nothing used for irrigation of cs scar
PLACEBO_COMPARATOR: saline irrigation group; saline used for irrigation the cs scar before closure	Other: irrigation; irrigation the edges of the cs scar before closure
EXPERIMENTAL: betadine irrigation group; betadine used for irrigation of cs scar	Other: irrigation; irrigation the edges of the cs scar before closure

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital
• Investigators: Study Director: fady salah, lecturer, Director

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2018
• Primary Completion (ANTICIPATED): May 1, 2019
• Study Completion (ANTICIPATED): June 1, 2019

Study Registration Dates

• First Submitted: October 20, 2018
• First Submitted That Met QC Criteria: October 29, 2018
• First Posted (ACTUAL): October 31, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 31, 2018
• Last Update Submitted That Met QC Criteria: October 29, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: saline, betadine, cesarean scar infection
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Wound Infection
• Other Study ID Numbers: assistant professor2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No