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NCT06454227 Clinical Trial

Subcutaneous Lavage in Cesarean Section

Surgical Site Infection Clinical Trial

Official title:
Antiseptic Washing Prior to Skin Closure During Cesarean Delivery- A Randomized Control Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06454227
Other study ID # WASHCD-HMO-CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2024
Est. completion date December 1, 2025

Study information
Verified date May 2024
Source Hadassah Medical Organization
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 600
Est. completion date December 1, 2025
Est. primary completion date July 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - pregnant women undergoing cesarean delivery Exclusion Criteria: - pregnant women undergoing vaginal delivery

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Subcutaneous washing
subcutaneous washing with chlorhexidine gluconate prior to skin closure
• no subcutaneous washing
no washing

Locations
Country Name City State
Israel Hadassah Medical Organization Jerusalem

Sponsors (1)
Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary surgical site infection SSI infection rates 30 days after surgery
Secondary hospital stay length of hospital stay 30 days after surgery
Secondary wound healing assessment of the healing according to Southampton criteria: presence of inflammation, erythema or discharge 30 days after surgery
Secondary postpartum fever fever recording 30 days after surgery
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