What side effects are associated with this type of intervention?

Chlorhexidine, used for surgical skin preparation, can cause side effects such as skin irritation, allergic reactions, and rare cases of anaphylaxis. It may also stain the skin and mucous membranes. Systemic antibiotics, another common treatment for SSIs, can lead to gastrointestinal upset, allergic reactions, and antibiotic resistance.

What prior FDA approvals exist?

FDA-approved treatments for Surgical Site Infections (SSIs) that work by disrupting microbial cell membranes include Chlorhexidine and povidone-iodine. These antiseptics are commonly used for preoperative skin preparation to reduce the risk of SSIs by effectively eliminating or reducing the number of microorganisms on the skin.

What other types of research exist?

Promising novel alternatives to Chlorhexidine for preventing surgical site infections include Betadine-containing irrigations, which have shown superior bactericidal activity against multiple Gram-positive and Gram-negative strains. Additionally, the use of probiotics, such as Lactobacillus and Saccharomyces boulardii, has been effective in preventing Clostridium difficile-associated diarrhea, which can be a complication of SSIs. These alternatives offer different mechanisms of action and have demonstrated efficacy in clinical settings.

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Antiseptic

Aqueous vs Alcohol Chlorhexidine for Cesarean Section Infection

Phase 4

Waitlist Available

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 30 days post cesarean

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial is testing two different skin cleaning solutions to see which one better prevents infections after a cesarean section. The study involves patients who are having a cesarean delivery. The cleaning solutions work by killing germs on the skin before surgery to reduce the risk of infection. One solution has been compared to another in various studies for its effectiveness in reducing surgical site infections.

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.

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.

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 30 days post cesarean

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 30 days post cesarean

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 30 days post cesarean for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants with Surgical site Infection

Secondary study objectives

Antibiotic regimens (medication names) used to treat infection

Cost Savings

Number of Participants with sepsis

+2 more

Awards & Highlights

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.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial 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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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Chlorhexidine is an antimicrobial agent that disrupts microbial cell membranes, leading to cell death. This mechanism is crucial for preventing Surgical Site Infections (SSIs) as it effectively reduces the microbial load on the skin, minimizing the risk of infection during and after surgery. The use of Chlorhexidine in preoperative skin preparation has been shown to lower the incidence of SSIs, which is vital for improving patient outcomes and reducing healthcare costs associated with postoperative infections.