Chlorhexidine-Alcohol Versus Povidone-Iodine for Cesarean Antisepsis

Study Overview
=================
Brief Summary
-----------------
Primary Hypothesis: chlorhexidine gluconate alcohol skin antiseptic preparation is superior to povidone-iodine scrub and paint skin antiseptic preparation for prevention of cesarean related surgical site infection.

Detailed Description
-----------------
Patients who are considered likely to need cesarean delivery or who are planning cesarean will be recruited and consented for study participation during prenatal care and/or at time of admission to labor and delivery. Patients undergoing cesarean who meet inclusion/exclusion criteria will be randomized to one of two surgical preparations as listed above (1. Chlorhexidine Gluconate (CHG)-alcohol, or 2. Povidone Iodine (P-I) scrub and paint. Randomization will be performed by the consenting surgeon (listed as key personnel) after the patient has arrived into the operating room for cesarean. Pre-operative surgical site antisepsis will be performed according to randomization. All other surgical practices will remain at the surgeon's discretion according to standard of care at Metrohealth. Patients will be examined daily by the obstetric team and evaluated for signs and symptoms of surgical site infection, as standard in the investigators institution. The chart will be reviewed to determine if the patient was diagnosed during admission, or, re-admitted because of surgical site infection. The patient will also be questioned regarding any treatment or diagnosis of Surgical Site Infection (SSI) that occured after discharge to home at the routine six week post-operative visit. If patient does not return for the routine post-operative visit, the investigator will attempt to contact the patient by telephone to determine if the patient had been diagnosed or treated for surgical site infection. If patient is lost to 6 week follow up, subanalysis will be performed on available data derived from hospitalization and hospital Electronic Medical Record (EMR). Data will be captured in RedCAP database. Additional data will be captured that may affect patient likelihood of surgical site infection to ensure that both groups are statistically equal in risk factors for SSI: labor or rupture of membranes prior to cesarean, maternal age, estimated gestational age, Body Mass Index (BMI), gravity, parity, race, smoking status, hypertensive morbidity, diabetes, estimated blood loss, operative time, race, insurance type, general versus regional anesthesia, appropriate antibiotic prophylaxis given, skin closure (sutures v. staples). Power analysis was performed: assuming 7.5% risk of cesarean site infection and a 50% reduction with chlorhexidine, 932 individuals will be recruited. Approximately 800 cesareans are performed at the investigators institution per year and the investigators anticipate that 80% will be eligible to participate. Data review will be done every 6 months or every 200 patients and analyzed, whichever is sooner. Analysis will be performed by the Primary Investigators (PI) for completeness, accuracy, strict adherence to study protocol, safety, and statistical significance. The investigators site is also subject to periodic audits by the investigators Institutional Review Board (IRB).

Official Title
-----------------
Chlorhexidine-Alcohol Versus Povidone-Iodine for Surgical Site Antisepsis Prior to Cesarean Delivery

Conditions
-----------------
Surgical Site Infection

Intervention / Treatment
-----------------
* Drug: Chlorhexidine - Isopropyl alcohol
* Drug: Povidone-Iodine Scrub and Paint


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cesarean delivery age 18-65 ability to consent in English or Spanish Exclusion Criteria: inability or unwillingness to consent to study participation in English or Spanish current incarceration pre-operative diagnosis of chorioamnionitis perceived inability to complete follow up for data collection any prior known allergy or adverse reaction to either study preparation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chlorhexidine - Isopropyl alcohol<br>Pre-operative skin preparation with Chlorhexidine Gluconate- Isopropyl alcohol | Drug: Chlorhexidine - Isopropyl alcohol<br>* Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA<br>* Other names: Chlora-Prep;|
| Experimental: Povidone-Iodine Scrub and Paint<br>Pre-operative skin preparation with Povidone-Iodine Scrub and Paint | Drug: Povidone-Iodine Scrub and Paint<br>* Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA<br>* Other names: Betadine;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Surgical Site Infection | Number of Patients with Cesarean-Related surgical site infection by Center for Disease Control (CDC) criteria: superficial, deep, organ space. | 4 weeks after cesarean delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Non-infections Surgical Site Complications | Non-infection complications: allergic skin reactions, hematomas, wound separation, dehiscence. | 4 weeks after cesarean delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Surgical site infection, Surgical site antisepsis, Cesarean Delivery