Aqueous vs Alcohol Chlorhexidine for Cesarean Section Infection

Overseen By Carrie Bennett, MD

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: Yaneve Fonge

Disqualifiers: Allergy to chlorhexidine, Chorioamnionitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two different skin antiseptics to determine which better prevents infections after a cesarean section (C-section). One group will use a solution with 2% Chlorhexidine and alcohol, while the other will use a 4% Chlorhexidine water-based solution. The study aims to identify the more effective and cost-efficient option. Women undergoing a C-section at Magee Women's Hospital, without allergies to the antiseptics, may qualify for this trial. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, aiming to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What is the safety track record for these treatments?

Research has shown that both 2% Chlorhexidine with alcohol and 4% Chlorhexidine in water are generally safe for preparing skin before surgery. The 2% Chlorhexidine with alcohol solution, often called ChloraPrep, effectively reduces infections at surgical sites and is well-tolerated, indicating its safety for cesarean sections.

Similarly, the 4% Chlorhexidine in water, known as Hibiclens, is considered safe. It is widely used for pre-surgical skin cleaning and has been shown to lower infection rates. It cleans without leaving harmful residues and is generally well-tolerated by patients.

Overall, extensive use and research support the safety and effectiveness of both treatments for preparing skin before surgery. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this trial comparing antiseptic methods for C-section surgeries because it explores two different formulations of chlorhexidine, a common surgical antiseptic, to see which one might better prevent infections. The study compares an alcohol-based solution, 2% chlorhexidine gluconate with 70% alcohol, which is known for its rapid antiseptic action, with a 4% chlorhexidine gluconate aqueous solution that might offer prolonged protection. Understanding the effectiveness of these formulations could lead to improved infection control, reducing risks for mothers undergoing cesarean sections. By investigating these two approaches, researchers hope to identify a superior method that enhances patient safety during and after surgery.

What evidence suggests that this trial's treatments could be effective for preventing cesarean section wound infections?

This trial will compare the effectiveness of two antiseptic solutions in preventing infections after cesarean sections. Research has shown that a mix of 2% chlorhexidine gluconate and 70% alcohol (CHG-IPA), which participants in one arm of this trial will receive, lowers the risk of infections after cesarean sections. Studies have found it effective for these surgeries and others. One review even suggested that CHG-IPA might be the best antiseptic for preventing infections after cesarean deliveries.

Participants in another arm of this trial will receive 4% chlorhexidine gluconate in water. The evidence for this solution is less clear. A small study showed it reduced bacteria, but another study found no change in infection rates. Overall, alcohol-based chlorhexidine appears more effective. ^{2 3 6 7 8}

Who Is on the Research Team?

Yaneve Fonge, MD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Women undergoing cesarean delivery at Magee Women's Hospital

Exclusion Criteria

Inability to obtain consent (language barrier, emergency cesarean section etc.)

Chorioamnionitis

Bowel injury at time of cesarean section

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either 4% Chlorhexidine Gluconate aqueous solution or 2% Chlorhexidine with isopropyl alcohol for cesarean section skin preparation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for surgical site infections and other complications post-cesarean delivery

90 days

What Are the Treatments Tested in This Trial?

Interventions

• 2% Chlorhexidine gluconate with 70% alcohol
• 4% Chlorhexidine Gluconate aqueous solution

Trial Overview 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.

How Is the Trial Designed?

Group I: 4% chlorhexidine gluconate (Hibiclens) Experimental Treatment 1 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 Treatment 1 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)

Who Is Running the Clinical Trial?

Yaneve Fonge

Lead Sponsor

Trials

1

Recruited

1,500+

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4777327/

A Randomized Trial Comparing Skin Antiseptic Agents at ... The use of chlorhexidine–alcohol for preoperative skin antisepsis resulted in a significantly lower risk of surgical-site infection after cesarean delivery than ...

2. journals.lww.com journals.lww.com/international-journal-of-surgery/fulltext/2024/11000/evaluation_of_the_efficacy_of.48.aspx

Evaluation of the efficacy of chlorhexidine-alcohol vs.... Chlorhexidine in alcohol worked effectively for general surgery, cesarean sections, and other surgeries.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0195670124001282

Review Which antiseptic to use for a caesarean section? ... Chlorhexidine 2% in an alcohol-based solution was most likely to be effective in preventing surgical site infections after caesarean section, followed by ...

4. thelancet.com thelancet.com/journals/lanmic/article/PIIS2666-5247(22)00187-2/fulltext

Efficacy of different preoperative skin antiseptics on ... This network meta-analysis provides evidence for a benefit of all different chlorhexidine in alcohol concentrations, 2·0–2·5% chlorhexidine in ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05920122?term=Chlorhexidine%20AND%20Isopropyl%20Alcohol&rank=6

Aqueous vs Alcohol Chlorhexidine Skin Preparation for ... This will be a single-center randomized control trial comparing the efficacy of two different formulations of Chlorhexidine surgical skin preparation in ...

6. bd.com bd.com/en-us/products-and-solutions/products/product-brands/chloraprep

BD ChloraPrep™ Patient Preoperative Skin Preparation ChloraPrep™ is the first antiseptic solution with a 2% chlorhexidine gluconate (CHG) ... Proven broad spectrum, rapid acting antiseptic combination of 2% CHG and ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0195670122002717

Antimicrobial persistence of two alcoholic preoperative skin ... A clinical study comparing the skin antisepsis and safety of ChloraPrep, 70% isopropyl alcohol, and 2% aqueous chlorhexidine. J Infus Nurs, 25 (2002), pp ...

8. ijponline.biomedcentral.com ijponline.biomedcentral.com/articles/10.1186/s13052-025-02016-5

The use of 2% chlorhexidine gluconate in 70% isopropyl ... 2% chlorhexidine gluconate in a 70% alcohol solution is considered the gold standard for skin disinfection in adult and paediatric patients prior to insertion ...