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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
1,398
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)
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.
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Number of Participants with Surgical site Infection
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.
Time frame: Within 30 days post cesarean
Number of Participants With Endometritis
Time frame: Within 30 days post cesarean
Number of Participants with intrabdominal/pelvic abscess
Time frame: Within 90 days post cesarean
Number of Participants with necrotizing fasciitis
Time frame: Within 90 days post cesarean
Number of Participants with sepsis
With wound/uterine infection as the source
Time frame: Within 90 days post cesarean
Length of Hospital Stay
Time frame: Within 90 days post cesarean
Number of Participants With Re-admissions or Office Visits for Wound-related Problems
Time frame: Within 90 days post cesarean
Number of Participants with ICU admission for wound infectious complications
Time frame: Within 90 days post cesarean
Number of Participants with Need for wound opening, exploration, or washout in the operating room
Time frame: Within 90 days post cesarean
Number of Participants who needed wound vacuum
Time frame: Within 90 days post cesarean
Number of Participants who needed home health
Time frame: Within 90 days post cesarean
Number of patients who needed antibiotics
will also collect route of antibiotic administration and duration of treatment to assist with cost analysis
Time frame: Within 90 days post cesarean
Number of doses of antibiotic treatment
for wound infection complications
Time frame: Within 90 days post cesarean
Antibiotic regimens (medication names) used to treat infection
for wound infection complications
Time frame: Within 90 days post cesarean
Number of participants with positive culture from wound
Time frame: Within 90 days post cesarean
The type of bacterial species isolated from wound infection cultures
Time frame: Within 90 days post cesarean
Number of participants with hematoma
Time frame: Within 90 days post cesarean
Number of participants with seroma
Time frame: Within 30 days post cesarean
Number of Participants With Skin Irritation
Time frame: within 48 hours from delivery
Number of Participants With Allergic Reaction
Time frame: within 48 hours from delivery
Cost Savings
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.
Time frame: Within 90 days post cesarean
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