Subcutaneous Lavage in Cesarean Section

Not Applicable

Recruiting

• Conditions: Surgical Site Infection
• Interventions: Procedure: Subcutaneous washing; Procedure: no subcutaneous washing

• Registration Number: NCT06454227
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

The goal of this clinical trial is to learn if antiseptic washing prior to skin closure during cesarean section reduces rates of surgical site infection.

intraoperative washing is a common practice in other surgical fields and several studies have shown efficacy in reducing postoperative infection rates. no randomized control trial has tested this intervention during cesarean section.

The main questions we aim to answer are:

Does subcutaneous antiseptic washing reduce the rates of surgical site infection? Does antiseptic washing improve scar healing? Does antiseptic washing reduce hospital stay, postpartum fever rates and readmission cases?

Researchers will compare subcutaneous antiseptic washing to no intervention to see if surgical site infection rates reduce

Participants will:

consent to participate in the trial Visit the postpartum clinic 30 days after surgery

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-07
• Study First Submitted QC: 2024-06-08
• Study First Posted: 2024-06-12
• Study Start: 2024-09-22
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-19
• Primary Completion: 2027-10-01
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

• pregnant women undergoing cesarean delivery

Exclusion Criteria

• pregnant women undergoing vaginal delivery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subcutan lavage	Subcutaneous washing	Subcutaneous washing with antiseptic solution: Chlorhexidine gluconate 0.2%
no lavage	no subcutaneous washing	No subcutaneous washing

Primary Outcome Measures

Name	Time	Method
surgical site infection	30 days after surgery	SSI infection rates

Secondary Outcome Measures

Name	Time	Method
wound healing	30 days after surgery	assessment of the healing according to Southampton criteria: presence of inflammation, erythema or discharge
hospital stay	30 days after surgery	length of hospital stay
postpartum fever	30 days after surgery	fever recording

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel