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

Study Overview
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Brief Summary
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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.

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

Conditions
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Surgical Site Infection, Cesarean Section; Infection

Intervention / Treatment
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* Drug: 2% Chlorhexidine gluconate with 70% alcohol
* Drug: 4% Chlorhexidine Gluconate aqueous solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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 : Regular contractions with cervical dilation of 4 cm or more OR Documented cervical change of at least 1 cm of dilation or at least 50% effacement OR Rupture of membranes
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2% Chlorhexidine gluconate with 70% alcohol (ChloraPrep)<br>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) | Drug: 2% Chlorhexidine gluconate with 70% alcohol<br>* 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)<br>* Other names: ChloraPrep;|
| Experimental: 4% chlorhexidine gluconate (Hibiclens)<br>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. | Drug: 4% Chlorhexidine Gluconate aqueous solution<br>* 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.<br>* Other names: Hibiclens;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Within 30 days post cesarean | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Endometritis |  | Within 30 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 | With wound/uterine infection as the source | Within 90 days post cesarean | 
| 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 patients who needed antibiotics | will also collect route of antibiotic administration and duration of treatment to assist with cost analysis | Within 90 days post cesarean | 
| Number of doses of antibiotic treatment | for wound infection complications | Within 90 days post cesarean | 
| Antibiotic regimens (medication names) used to treat infection | for wound infection complications | Within 90 days post cesarean | 
| 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 | 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. | Within 90 days post cesarean |