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

Yaneve Fonge

Status and phase: Active, not recruiting; Phase 4

Conditions: Surgical Site Infection; Cesarean Section; Infection

Treatments: Drug: 4% Chlorhexidine Gluconate aqueous solution; Drug: 2% Chlorhexidine gluconate with 70% alcohol

Study type: Interventional

Funder types: Other

Identifiers

NCT05920122

STUDY23030049

Details and patient eligibility

About

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.

Enrollment: 1,470 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women undergoing cesarean delivery at Magee Women's Hospital

Exclusion criteria

• Inability to obtain consent (language barrier, emergency cesarean section etc.)
• Allergy to chlorhexidine or alcohol
• Chorioamnionitis
• Emergency cesareans where cannot wait for chlorhexidine alcohol to dry
• bowel injury at time of cesarean section
• Women who are delivered at another institution and are transferred postpartum to Magees Women's Hospital

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,470 participants in 2 patient groups

2% Chlorhexidine gluconate with 70% alcohol (ChloraPrep)

Experimental group

Description:

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)

Treatment:

Drug: 2% Chlorhexidine gluconate with 70% alcohol

4% chlorhexidine gluconate (Hibiclens)

Experimental group

Description:

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.

Treatment:

Drug: 4% Chlorhexidine Gluconate aqueous solution