Subcutaneous Lavage in Cesarean Section
ConditionSurgical Site Infection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorHadassah Medical Organization
About this 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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
pregnant women undergoing cesarean delivery
Disqualifiers
pregnant women undergoing vaginal delivery
Trial design
Design model
Single group
Treatments tested in this trial
Subcutaneous washing
Procedure/Surgerysubcutaneous washing with chlorhexidine gluconate prior to skin closure
no subcutaneous washing
Procedure/Surgeryno washing
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: Subcutan lavageActive comparator 1 intervention
Group B: no lavagePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
surgical site infection
SSI infection rates
Time frame
30 days after surgerySecondary outcomes
1
hospital stay
length of hospital stay
Time frame
30 days after surgery2
wound healing
assessment of the healing according to Southampton criteria: presence of inflammation, erythema or discharge
Time frame
30 days after surgery3
postpartum fever
fever recording
Time frame
30 days after surgerySponsors and contacts
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Source ClinicalTrials.gov