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Perioperative Patient Skin Antiseptic Preparation Evaluation

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ClinicalTrials.gov Identifier: NCT04756804
Recruitment Status : Recruiting
First Posted : February 16, 2021
Last Update Posted : October 12, 2021
Sponsor:
Information provided by (Responsible Party):
Zurex Pharma, Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Surgical Site Infection Drug: 70% v/v Isopropyl Alcohol Surgical Solution Drug: 2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized, Controlled Clinical Trial Evaluating A Novel Perioperative Patient Skin Antiseptic Preparation
Actual Study Start Date : June 21, 2021
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2022

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Arms and Interventions
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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 Name: 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 Name: ChloraPrep


Outcome Measures
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Primary Outcome Measures :
  1. Surgical Site infection occurrence [ Time Frame: Within 30 days after surgery ]
    The primary objective is to demonstrate efficacy in surgical use through the rate of surgical site infections.

  2. Allergic reaction and skin irritation [ Time Frame: Within 30 days after surgery ]
    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.


Secondary Outcome Measures :
  1. Subgroup analysis of rates of surgical site infections [ Time Frame: Within 30 days after surgery ]
    Surgical site infection rates by different infection types classified as superficial incisional infection, deep incisional infection, or organ-space infection.

  2. Subgroup analysis of rates of surgical site infections [ Time Frame: Within 30 days after surgery ]
    Surgical site infection rates by type of surgery including clean (class I wound) or clean-contaminated (class II wounds) surgeries


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04756804


Contacts
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Contact: Elizabeth Weseman, RN,BSN 414.955.1800 eweseman@mcw.edu

Locations
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United States, Wisconsin
MCW/FH Recruiting
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Zurex Pharma, Inc.
Investigators
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Principal Investigator: Joseph P Hart, MD, FACS, DFSVS Medical College of Wisconsin
More Information
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Responsible Party: Zurex Pharma, Inc.
ClinicalTrials.gov Identifier: NCT04756804    
Other Study ID Numbers: ZXZP0113
First Posted: February 16, 2021    Key Record Dates
Last Update Posted: October 12, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Surgical Wound Infection
Wound Infection
Infections
Postoperative Complications
Pathologic Processes
Ethanol
Chlorhexidine
 Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Disinfectants
Dermatologic Agents