Clinical trial NCT03725748: Normal Saline Versus Betadine Use to Reduce the Incidence of Wound Infection in Cesarean Section
Official title: Normal Saline Versus Betadine Use to Reduce the Incidence of Wound Infection in Cesarean
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Incidence of cs Scar Infection
Keywords: saline, betadine, cesarean scar infection
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2018-10-31
Enrollment: 300
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: incidence of cs scar infection
timeFrame: 2 to 6 weeks
Secondary outcomes:
measure: incidence of hematoma, seroma
timeFrame: 2 to 6 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr El Ainy
Study officials:
affiliation: Director
name: fady salah, lecturer
role: STUDY_DIRECTOR
References: