NCT05920122

Aqueous vs Alcohol Chlorhexidine Skin Preparation for Prevention of Cesarean Section Wound Infections

A Randomized Control Trial of Chlorhexidine Gluconate Aqueous Solution vs Chlorhexidine Gluconate With Isopropyl Alcohol Skin Preparations for Prevention of Cesarean Section Wound Infections

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,398 (actual)
• Sponsor: Hyagriv Simhan · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This will be a single-center randomized control trial comparing the efficacy of two different formulations of Chlorhexidine surgical skin preparation in preventing cesarean section wound infections. Participants will be randomized to either 4% Chlorhexidine Gluconate aqueous solution (CHG) or 2% Chlorhexidine with isopropyl alcohol (CHG-IPA) 70% to examine the risk of infectious morbidity in those undergoing cesarean delivery. There will also be a cost-effectiveness analysis of the two preoperative skin preparations.

Conditions

• Surgical Site Infection
• Cesarean Section; Infection

Interventions

Type	Name	Description
DRUG	2% Chlorhexidine gluconate with 70% alcohol	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)
DRUG	4% Chlorhexidine Gluconate aqueous solution	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.

Timeline

• Start date: 2023-10-09
• Primary completion: 2025-10-17
• Completion: 2025-10-17
• First posted: 2023-06-27
• Last updated: 2026-01-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study