Perioperative Patient Skin Antiseptic Preparation Evaluation

Zurex Pharma, Inc.51 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Surgical Site Infection

Interventions

70% v/v Isopropyl Alcohol Surgical SolutionDRUG

Patient preoperative skin preparation

2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl AlcoholDRUG

Patient preoperative skin preparation

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Be male or female and at least 18 years of age. 2. 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. 3. Be planning to undergo clean (class I wound) or clean-contaminated (class II wounds) surgery. 4. Expect to be available for up to 30-days after the surgery. Exclusion Criteria: 1. Active infection or fever including evidence of infection at or adjacent to the operative site. 2. Immunosuppressed. 3. Kidney/liver failure. 4. Immunosuppressive therapy (chemotherapy, steroids) within the previous 1 week. 5. 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.

Locations (1)

MCW/FH

Milwaukee, Wisconsin, United States

Outcomes

Primary Outcomes

Surgical Site Infection Occurrence

The primary objective is to demonstrate efficacy in surgical use through the rate of surgical site infections.

Time frame: 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.

Time frame: Within 30 days after surgery

Secondary Outcomes

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.

Time frame: 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

Time frame: Within 30 days after surgery

Data from ClinicalTrials.gov

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