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Completed

NCT Number: NCT05920122

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

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.

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Key information

Conditions

Surgical Site Infection Cesarean Section; Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2% Chlorhexidine gluconate with 70% alcohol

Drug

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)

Other names: ChloraPrep

4% Chlorhexidine Gluconate aqueous solution

Drug

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.

Other names: Hibiclens

Primary outcomes

  1. Number of Participants with Surgical site Infection

    Time frame: Within 30 days post cesarean

    Superficial or deep surgical-site infection within 30 days after cesarean delivery, on the basis of the National Healthcare Safety Network definitions of the Centers for Disease Control and Prevention.

Secondary outcomes

  1. Number of Participants With Endometritis

    Time frame: Within 30 days post cesarean

  2. Number of Participants with intrabdominal/pelvic abscess

    Time frame: Within 90 days post cesarean

  3. Number of Participants with necrotizing fasciitis

    Time frame: Within 90 days post cesarean

  4. Number of Participants with sepsis

    Time frame: Within 90 days post cesarean

    With wound/uterine infection as the source

  5. Length of Hospital Stay

    Time frame: Within 90 days post cesarean

  6. Number of Participants With Re-admissions or Office Visits for Wound-related Problems

    Time frame: Within 90 days post cesarean

  7. Number of Participants with ICU admission for wound infectious complications

    Time frame: Within 90 days post cesarean

  8. Number of Participants with Need for wound opening, exploration, or washout in the operating room

    Time frame: Within 90 days post cesarean

  9. Number of Participants who needed wound vacuum

    Time frame: Within 90 days post cesarean

  10. Number of Participants who needed home health

    Time frame: Within 90 days post cesarean

  11. Number of patients who needed antibiotics

    Time frame: Within 90 days post cesarean

    will also collect route of antibiotic administration and duration of treatment to assist with cost analysis

  12. Number of doses of antibiotic treatment

    Time frame: Within 90 days post cesarean

    for wound infection complications

  13. Antibiotic regimens (medication names) used to treat infection

    Time frame: Within 90 days post cesarean

    for wound infection complications

  14. Number of participants with positive culture from wound

    Time frame: Within 90 days post cesarean

  15. The type of bacterial species isolated from wound infection cultures

    Time frame: Within 90 days post cesarean

  16. Number of participants with hematoma

    Time frame: Within 90 days post cesarean

  17. Number of participants with seroma

    Time frame: Within 30 days post cesarean

  18. Number of Participants With Skin Irritation

    Time frame: within 48 hours from delivery

  19. Number of Participants With Allergic Reaction

    Time frame: within 48 hours from delivery

  20. Cost Savings

    Time frame: Within 90 days post cesarean

    costs (dollars) associated with a hospital stay, office visits and re-admissions for infection-related complications, ICU admission for infectious complications, wound exploration or washout in the operating room, wound vacuum use, home health, antibiotic prescriptions, and duration of treatment will be collected and used to calculate the cost of wound infection management. The cost difference between groups will be calculated to estimate cost savings.

Sponsors and collaborators

Lead sponsor

Hyagriv Simhan

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 27, 2023
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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