Aqueous vs Alcohol Chlorhexidine for Cesarean Section Infection

Recruiting in Palo Alto (17 mi)

Overseen byYaneve Fonge, MD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Yaneve Fonge

No Placebo Group

Prior Safety Data

Trial Summary

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

See 3 more

Treatment Details

Interventions

2% Chlorhexidine gluconate with 70% alcohol (Antiseptic)
4% Chlorhexidine Gluconate aqueous solution (Antiseptic)

Trial OverviewThe 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

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)