Subcutaneous Lavage in Cesarean Section | NCT06454227

Studies
Subcutaneous Lavage in Cesarean Section

NCT06454227

Sponsor

Hadassah Medical Organization

Status

Recruiting

Last Update Posted

Mar 19, 2025Actual

Enrollment

600Estimated

Phase

Not Applicable

Conditions

Surgical Site Infection

Interventions

Subcutaneous washing
no subcutaneous washing

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 22, 2024Actual

Primary Completion Date

Oct 1, 2027Estimated

Completion Date

Dec 1, 2028Estimated

First Submitted Date

May 7, 2024

First Submission Date that Met QC Criteria

Jun 8, 2024

First Posted Date

Jun 12, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2025

Last Update Posted Date

Mar 19, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Subcutaneous washing	Procedure	subcutaneous washing with chlorhexidine gluconate prior to skin closure	Subcutan lavage

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
surgical site infection	SSI infection rates	30 days after surgery

Secondary Outcomes

Measure	Description	Time Frame
hospital stay	length of hospital stay	30 days after surgery
wound healing	assessment of the healing according to Southampton criteria: presence of inflammation, erythema or discharge

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

pregnant women undergoing cesarean delivery

Exclusion Criteria:

pregnant women undergoing vaginal delivery

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

pregnant women undergoing cesarean delivery

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization	Recruiting	Jerusalem			Israel

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013530	Surgical Wound Infection

Ancestor Terms

ID	Term
D014946	Wound Infection
D007239	Infections
D011183	Postoperative Complications
D010335	Pathologic Processes

Browse Leaves

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Browse Branches

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