Perioperative Patient Skin Antiseptic Preparation Evaluation

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

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 Overview

• Status: Completed
• Conditions: Surgical Site Infection
• Intervention / Treatment: Drug: 70% v/v Isopropyl Alcohol Surgical Solution; Drug: 2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • MCW/FH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zurex Pharma, Inc.
• Investigators: Principal Investigator: Joseph P Hart, MD, FACS, DFSVS, Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2021
• Primary Completion (Actual): September 29, 2022
• Study Completion (Actual): September 29, 2022

Study Registration Dates

• First Submitted: February 11, 2021
• First Submitted That Met QC Criteria: February 11, 2021
• First Posted (Actual): February 16, 2021

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Postoperative Complications; Wound Infection; Surgical Wound Infection; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Dermatologic Agents; Disinfectants; Ethanol; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: ZXZP0113

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No