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

Kasr El Aini Hospital

Status and phase: Unknown; Phase 2

Conditions: Incidence of cs Scar Infection

Treatments: Other: irrigation

Study type: Interventional

Funder types: Other

Identifiers

NCT03725748

assistant professor2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 19 to 37 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 3 patient groups, including a placebo group

no irrigation group

No Intervention group

Description:

nothing used for irrigation of cs scar

saline irrigation group

Placebo Comparator group

Description:

saline used for irrigation the cs scar before closure

Treatment:

Other: irrigation

betadine irrigation group

Experimental group

Description:

betadine used for irrigation of cs scar

Treatment:

Other: irrigation