Perioperative Patient Skin Antiseptic Preparation Evaluation

Surgical Site Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04756804
• Other study ID #: ZXZP0113
• Status: Completed
• Phase: Phase 3
• Start date: June 21, 2021
• Est. completion date: September 29, 2022

Study information

• Verified date: February 2024
• Source: Zurex Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: September 29, 2022
• Est. primary completion date: September 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Surgical Site Infection
• Surgical Wound Infection

Intervention

Drug:
• 70% v/v Isopropyl Alcohol Surgical Solution
Patient preoperative skin preparation
• 2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol
Patient preoperative skin preparation

Locations

Country	Name	City	State
United States	MCW/FH	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Zurex Pharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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