Perioperative Patient Skin Antiseptic Preparation Evaluation

Study Overview
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Brief Summary
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This study will evaluate a new topical skin antiseptic perioperative preparation and the standard of care to determine efficacy on the rates of surgical site infections of surgical patients. Safety will also be assessed.

Official Title
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A Randomized, Controlled Clinical Trial Evaluating A Novel Perioperative Patient Skin Antiseptic Preparation

Conditions
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Surgical Site Infection

Intervention / Treatment
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* Drug: 70% v/v Isopropyl Alcohol Surgical Solution
* Drug: 2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be male or female and at least 18 years of age. Be able to verbalize an understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English. Be planning to undergo clean (class I wound) or clean-contaminated (class II wounds) surgery. Expect to be available for up to 30-days after the surgery. Exclusion Criteria: Active infection or fever including evidence of infection at or adjacent to the operative site. Immunosuppressed. Kidney/liver failure. Immunosuppressive therapy (chemotherapy, steroids) within the previous 1 week. Any history of allergy to chlorhexidine or isopropyl alcohol or any other component in ZuraGard including citric acid, sodium citrate, methylparaben, or propylparaben, and FD&C Yellow #6.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 70% Isopropyl Alcohol novel preoperative skin antiseptic<br>70% v/v Isopropyl Alcohol novel preoperative skin antisepsis preparation | Drug: 70% v/v Isopropyl Alcohol Surgical Solution<br>* Patient preoperative skin preparation<br>* Other names: ZuraGard;|
| Active Comparator: 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol preoperative skin antiseptic<br>2% Chlorhexidine Gluconate/70% Isopropyl Alcohol preoperative skin antisepsis preparation | Drug: 2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol<br>* Patient preoperative skin preparation<br>* Other names: ChloraPrep;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Site infection occurrence | The primary objective is to demonstrate efficacy in surgical use through the rate of surgical site infections. | Within 30 days after surgery | 
| Allergic reaction and skin irritation | The primary safety objective is to determine the rates of skin irritation or allergic reactions attributed to each drug product and all other adverse events. | Within 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subgroup analysis of rates of surgical site infections | Surgical site infection rates by different infection types classified as superficial incisional infection, deep incisional infection, or organ-space infection. | Within 30 days after surgery | 
| Subgroup analysis of rates of surgical site infections | Surgical site infection rates by type of surgery including clean (class I wound) or clean-contaminated (class II wounds) surgeries | Within 30 days after surgery |