Cesarean Section; Infection, Surgical Site Infection
Conditions
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.
Interventions
DRUG2% 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)
DRUG4% 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
Hyagriv Simhan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The provider making the diagnosis of wound infection will be blinded to the intervention
Intervention model description
Immediately prior to entering the operating room, participants will be randomly assigned in a 1:1 ratio to the CHG or CHG-IPA group. Groups will be stratified by laboring status defined as : 1. Regular contractions with cervical dilation of 4 cm or more OR 2. Documented cervical change of at least 1 cm of dilation or at least 50% effacement OR 3. Rupture of membranes
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Length of Hospital Stay | Within 90 days post cesarean | — |
| 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 Participants with Need for wound opening, exploration, or washout in the operating room | 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 Participants With Endometritis | Within 30 days post cesarean | — |
| Number of doses of antibiotic treatment | Within 90 days post cesarean | for wound infection complications |
| Antibiotic regimens (medication names) used to treat infection | 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 seroma | Within 30 days post cesarean | — |
| Number of Participants With Skin Irritation | within 48 hours from delivery | — |
| Number of Participants With Allergic Reaction | 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. |
| 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 |
Countries
United States
Outcome results
None listed