Subcutaneous Lavage in Cesarean Section

NCT ID: NCT06454227

Last Updated: 2025-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-22

Study Completion Date

2028-12-01

Brief Summary

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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

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Conditions

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Surgical Site Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Subcutan lavage

Subcutaneous washing with antiseptic solution: Chlorhexidine gluconate 0.2%

Group Type ACTIVE_COMPARATOR

Subcutaneous washing

Intervention Type PROCEDURE

subcutaneous washing with chlorhexidine gluconate prior to skin closure

no lavage

No subcutaneous washing

Group Type PLACEBO_COMPARATOR

no subcutaneous washing

Intervention Type PROCEDURE

no washing

Interventions

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Subcutaneous washing

subcutaneous washing with chlorhexidine gluconate prior to skin closure

Intervention Type PROCEDURE

no subcutaneous washing

no washing

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* pregnant women undergoing cesarean delivery

Exclusion Criteria

* pregnant women undergoing vaginal delivery
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hadassah Medical Organization

Jerusalem, , Israel

Site Status RECRUITING

Countries

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Israel

Facility Contacts

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Hadas Lemberg, PhD

Role: primary

00 972 2 6777572

Other Identifiers

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WASHCD-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id

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