Aqueous Vs Alcohol Chlorhexidine Skin Preparation for Prevention of Cesarean Section Wound Infections
- Conditions
- Surgical Site InfectionCesarean Section; Infection
- Interventions
- Registration Number
- NCT05920122
- Lead Sponsor
- Yaneve Fonge
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 1470
- Women undergoing cesarean delivery at Magee Women's Hospital
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2% Chlorhexidine gluconate with 70% alcohol (ChloraPrep) 2% Chlorhexidine gluconate with 70% alcohol 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) 4% chlorhexidine gluconate (Hibiclens) 4% Chlorhexidine Gluconate aqueous solution 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.
- Primary Outcome Measures
Name Time Method Number of Participants with Surgical site Infection 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 Outcome Measures
Name Time Method Length of Hospital Stay Within 90 days post cesarean Number of Participants who needed wound vacuum Within 90 days post cesarean Number of Participants who needed home health Within 90 days post cesarean Number of doses of antibiotic treatment Within 90 days post cesarean for wound infection complications
Number of participants with positive culture from wound Within 90 days post cesarean The type of bacterial species isolated from wound infection cultures Within 90 days post cesarean Number of participants with hematoma Within 90 days post cesarean Number of Participants with intrabdominal/pelvic abscess Within 90 days post cesarean Number of Participants with necrotizing fasciitis Within 90 days post cesarean Number of Participants with sepsis Within 90 days post cesarean With wound/uterine infection as the source
Number of Participants with Need for wound opening, exploration, or washout in the operating room Within 90 days post cesarean Number of Participants With Endometritis Within 30 days post cesarean Number of Participants With Allergic Reaction within 48 hours from delivery Number of Participants With Re-admissions or Office Visits for Wound-related Problems Within 90 days post cesarean Number of Participants with ICU admission for wound infectious complications Within 90 days post cesarean Number of patients who needed antibiotics Within 90 days post cesarean will also collect route of antibiotic administration and duration of treatment to assist with cost analysis
Antibiotic regimens (medication names) used to treat infection Within 90 days post cesarean for wound infection complications
Number of participants with seroma Within 30 days post cesarean Number of Participants With Skin Irritation within 48 hours from delivery Cost Savings 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.
Trial Locations
- Locations (1)
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States