Subcutaneous Lavage in Cesarean Section
Antiseptic Washing Prior to Skin Closure During Cesarean Delivery- a Randomized Control Trial
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Jerusalem, Israel
- Recruiting
- Hadassah Medical Organization
-
Contact:
- Hadas Lemberg, PhD
- Phone Number: 00 972 2 6777572
- Email: lhadas@hadassah.org.il
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- pregnant women undergoing cesarean delivery
Exclusion Criteria:
- pregnant women undergoing vaginal delivery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Subcutan lavage
Subcutaneous washing with antiseptic solution: Chlorhexidine gluconate 0.2%
|
subcutaneous washing with chlorhexidine gluconate prior to skin closure
|
|
Placebo Comparator: no lavage
No subcutaneous washing
|
no washing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
surgical site infection
Time Frame: 30 days after surgery
|
SSI infection rates
|
30 days after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
hospital stay
Time Frame: 30 days after surgery
|
length of hospital stay
|
30 days after surgery
|
|
wound healing
Time Frame: 30 days after surgery
|
assessment of the healing according to Southampton criteria: presence of inflammation, erythema or discharge
|
30 days after surgery
|
|
postpartum fever
Time Frame: 30 days after surgery
|
fever recording
|
30 days after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WASHCD-HMO-CTIL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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