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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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03725748
Enrollment
300
Registered
2018-10-31
Start date
2018-11-01
Completion date
2019-06-30
Last updated
2018-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incidence of cs Scar Infection

Keywords

saline, betadine, cesarean scar infection

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.

Interventions

irrigation the edges of the cs scar before closure

Sponsors

Kasr El Aini Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 37 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
incidence of cs scar infection2 to 6 weeksincidence of cs scar infection

Secondary

MeasureTime frameDescription
incidence of hematoma, seroma2 to 6 weeksincidence of hematoma, seroma, wound breakdown

Countries

Egypt

Contacts

Primary Contacthany saad, assistant prof
dr_hanysaad@yahoo.co.uk01001817211
Backup Contactashraf saad, lecturer
ashraf@yahoo.co.uk01001817221

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026