NCT06454227

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
31mo left

Started Sep 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress40%
Sep 2024Dec 2028

First Submitted

Initial submission to the registry

May 7, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 12, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

September 22, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

March 19, 2025

Status Verified

May 1, 2024

Enrollment Period

3 years

First QC Date

May 7, 2024

Last Update Submit

March 17, 2025

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

  • surgical site infection

    SSI infection rates

    30 days after surgery

Secondary Outcomes (3)

  • hospital stay

    30 days after surgery

  • wound healing

    30 days after surgery

  • postpartum fever

    30 days after surgery

Study Arms (2)

Subcutan lavage

ACTIVE COMPARATOR

Subcutaneous washing with antiseptic solution: Chlorhexidine gluconate 0.2%

Procedure: Subcutaneous washing

no lavage

PLACEBO COMPARATOR

No subcutaneous washing

Procedure: no subcutaneous washing

Interventions

Subcutaneous washingPROCEDURE

subcutaneous washing with chlorhexidine gluconate prior to skin closure

Subcutan lavage
no subcutaneous washingPROCEDURE

no washing

no lavage

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women undergoing cesarean delivery
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • pregnant women undergoing cesarean delivery

You may not qualify if:

  • pregnant women undergoing vaginal delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2024

First Posted

June 12, 2024

Study Start

September 22, 2024

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

December 1, 2028

Last Updated

March 19, 2025

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)