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

NCT05920122 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1398

Last updated 2026-01-07

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Hyagriv Simhan

    lead OTHER

Principal Investigators

  • Yaneve Fonge, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-09
Primary Completion
2025-10-17
Completion
2025-10-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05920122 on ClinicalTrials.gov