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

1470 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment 2% Chlorhexidine gluconate with 70% alcohol, 4% Chlorhexidine Gluconate aqueous solution for preventing infection after cesarean section?

Research shows that using chlorhexidine-alcohol for skin preparation before a cesarean section results in similar rates of surgical site infections compared to povidone-iodine, suggesting it is an effective antiseptic option. ^{1 2 3 4 5}

Is chlorhexidine safe for use in cesarean section procedures?

Chlorhexidine, whether in alcohol or aqueous form, is commonly used for skin antisepsis before cesarean sections and is generally considered safe. However, it is important to ensure that any ultrasound gel is thoroughly removed with isopropyl alcohol before applying chlorhexidine to reduce the risk of infection. ^{1 2 5 6 7}

How does the treatment of 2% Chlorhexidine gluconate with 70% alcohol differ from other treatments for cesarean section infection?

The treatment using 2% Chlorhexidine gluconate with 70% alcohol is unique because it combines chlorhexidine, which is a strong antiseptic, with alcohol to enhance its effectiveness in reducing surgical site infections compared to traditional povidone-iodine solutions. ^{1 2 4 5 8}

What is the purpose of this trial?

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.

Research Team

Yaneve Fonge, MD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

A randomized open-label controlled trial of chlorhexidine-alcohol vs povidone-iodine for cesarean antisepsis: the CAPICA trial. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Chlorhexidine-Alcohol Compared with Povidone-Iodine Preoperative Skin Antisepsis for Cesarean Delivery: A Systematic Review and Meta-Analysis. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Preoperative vaginal cleansing with chlorhexidine vs placebo in patients with rupture of membranes: a prospective, randomized, double-blind, placebo-control study. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Chlorhexidine-alcohol versus povidone-iodine for skin preparation before elective cesarean section: a prospective observational study. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Chlorhexidine-alcohol versus povidone-iodine as preoperative skin antisepsis for prevention of surgical site infection in cesarean delivery-a pilot randomized control trial. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

A potential method to lower risk for surgical site infection during cesarean birth. [2014]

7. England pubmed.ncbi.nlm.nih.gov

Aqueous chlorhexidine 1% versus 2% for neonatal skin antisepsis: a randomised non-inferiority trial. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Optimal skin antiseptic agents for prevention of surgical site infection in cesarean section: a meta-analysis with trial sequential analysis. [2018]