Perioperative Patient Skin Antiseptic Preparation Evaluation

NCT04756804 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: ZXZP0113
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Subgroup Analysis of Rates of Surgical Site Infections

  Within 30 days after surgery

• Subgroup Analysis of Rates of Surgical Site Infections

  Within 30 days after surgery

Study Arms (2)

70% Isopropyl Alcohol novel preoperative skin antiseptic

EXPERIMENTAL

70% v/v Isopropyl Alcohol novel preoperative skin antisepsis preparation

Drug: 70% v/v Isopropyl Alcohol Surgical Solution

2% Chlorhexidine Gluconate/70% Isopropyl Alcohol preoperative skin antiseptic

ACTIVE COMPARATOR

2% Chlorhexidine Gluconate/70% Isopropyl Alcohol preoperative skin antisepsis preparation

Drug: 2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol

Interventions

70% v/v Isopropyl Alcohol Surgical Solution DRUG

Patient preoperative skin preparation

Also known as: ZuraGard

70% Isopropyl Alcohol novel preoperative skin antiseptic

2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol DRUG

Patient preoperative skin preparation

Also known as: ChloraPrep

2% Chlorhexidine Gluconate/70% Isopropyl Alcohol preoperative skin antiseptic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zurex Pharma, Inc.: lead

Study Sites (1)

MCW/FH

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Limitations and Caveats

This was a pilot study of surgical patients, the majority of which had significant comorbidities with several AEs reported in more than one patient across the study.

Results Point of Contact

• Title: VP, Reg Affairs
• Organization: Zurex Pharma, Inc.

customercare@zurexpharma.com

608.203.9090

Study Officials

• Joseph P Hart, MD, FACS, DFSVS

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2021
• First Posted: February 16, 2021
• Study Start: June 21, 2021
• Primary Completion: September 29, 2022
• Study Completion: September 29, 2022
• Last Updated: March 20, 2024
• Results First Posted: March 20, 2024

Record last verified: 2024-02

Locations

US (1)