Wound Irrigation With Saline Versus Hypodilute-chlorhexidine After Cesarean Section (WISHES Study)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorLoma Linda University
About this trial
This investigator-initiated, open-label, randomized controlled trial will explore the effects of two treatment arms, comparing standard treatment with normal saline against Irrisept, a jet lavage solution containing a low concentration of Chlorhexidine Gluconate (CHG) at 0.05% in 99.95% sterile water for irrigation. The study aims to evaluate the impact on postoperative wound healing in patients who have undergone cesarean delivery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 or older
Singleton pregnancy
Planned cesarean delivery at gestational age 37 weeks or later at Loma Linda University Children's Hospital
Planned post-operative follow up with Loma Linda OBGYN
Disqualifiers
Emergency cesarean delivery
Trial design
Design model
Parallel
Treatments tested in this trial
Irrisept
Device450ml low concentration (0.05%) Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water
Normal Saline
Drug450mL
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: IrriseptExperimental treatment 1 intervention
Group B: Normal SalineActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Composite wound evaluation scale after caesarean delivery
Wound Evaluation scale will be used to evaluate appropriate healing in the following categories: redness, bruising, discharge, tissue breakdown, wound infection
Time frame
Up to 8 weeks postopSponsors and contacts
Click on the lead sponsor to view all of their trials.
Loma Linda University
Lead sponsor
Irrimax Corporation
Collaborator
Source ClinicalTrials.gov