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Antiseptic
Aqueous vs Alcohol Chlorhexidine for Cesarean Section Infection
Phase 4
Recruiting
Led By Yaneve Fonge, MD
Research Sponsored by Yaneve Fonge
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 48 hours from delivery
Awards & highlights
Study Summary
This trial will compare two solutions for skin prep before C-section to see which is more effective at preventing wound infection and cost-effective.
Who is the study for?
This trial is for women who are scheduled to have a cesarean delivery at Magee Women's Hospital. It aims to find out which skin cleaning method is better at preventing infections after surgery.Check my eligibility
What is being tested?
The study compares two ways of cleaning the skin before C-sections: one uses a water-based Chlorhexidine solution, and the other uses Chlorhexidine with alcohol. The goal is to see which one lowers infection risk more effectively.See study design
What are the potential side effects?
Possible side effects from using Chlorhexidine may include skin irritation or allergic reactions, but these are generally mild. Since it's applied externally, systemic side effects are rare.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 48 hours from delivery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 48 hours from delivery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with Surgical site Infection
Secondary outcome measures
Antibiotic regimens (medication names) used to treat infection
Cost Savings
Length of Hospital Stay
+17 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: 4% chlorhexidine gluconate (Hibiclens)Experimental Treatment1 Intervention
Including cases undergoing elective & nonelective caesarean section. Patients will be scrubbed preoperative with an applicator that contain 4% chlorohexidine aqueous solution (3 consecutive applications) liberally over 2 minutes followed by drying with sterile towel. The area scrubbed will be the same as the chloraprep group.
Group II: 2% Chlorhexidine gluconate with 70% alcohol (ChloraPrep)Experimental Treatment1 Intervention
Including cases undergoing elective &non elective caesarean section. Patients will be prepared similarly using the appropriate number of 26mL Chloraprep sticks for their body surface area. The lever will be pinched to activate the ampoule and release the antiseptic. The solution will be given time to partially load in the sponge. The sponge will be pressed against the skin area where the incision is intended moving back and forth for 30 sec , then working up towards the upper edge of the surgical field and then working from below the incision sight to the upper thighs. The antiseptic will be given time to dry (3 min)
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Who is running the clinical trial?
Yaneve FongeLead Sponsor
University of PittsburghLead Sponsor
1,723 Previous Clinical Trials
16,341,686 Total Patients Enrolled
Yaneve Fonge, MDPrincipal InvestigatorUniversity of Pittsburgh
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: 2% Chlorhexidine gluconate with 70% alcohol (ChloraPrep)
- Group 2: 4% chlorhexidine gluconate (Hibiclens)
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is 2% Chlorhexidine gluconate with 70% alcohol (ChloraPrep) a viable option for patient safety?
"Our team assigned ChloraPrep, a solution of 2% chlorhexidine gluconate and 70% alcohol, a score of 3 as this treatment is already approved for use in Phase 4 trials."
Answered by AI
Is participation in this medical trial open to the public?
"To be eligible for this trial, participants must have been diagnosed with surgical site infection and fall within the age range of 18 to 50. In total, 1470 individuals are recruited in this experiment."
Answered by AI
Is this trial open to individuals aged 25 or older?
"The ideal participant of this research project should be between 18-50 years old."
Answered by AI
Are there participation openings available for this research endeavor?
"The clinicaltrials.gov database has this trial marked as inactive, with the initial post dating back to July 1st 2023 and last edited on June 15th 2023. This study is not seeking out new participants at this time but there are 825 other trials actively looking for volunteers."
Answered by AI
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