Perioperative Patient Skin Antiseptic Preparation Evaluation

Phase 3

Completed

• Conditions: Surgical Site Infection
• Interventions: Drug: 70% v/v Isopropyl Alcohol Surgical Solution; Drug: 2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol

• Registration Number: NCT04756804
• Lead Sponsor: Zurex Pharma, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-11
• Study First Submitted QC: 2021-02-11
• Study First Posted: 2021-02-16
• Study Start: 2021-06-21
• Primary Completion: 2022-09-29
• Study Completion: 2022-09-29
• Results First Submitted: 2024-01-24
• Status Verified: 2024-02
• Results First Submitted QC: 2024-02-20
• Last Update Submitted: 2024-02-20
• Results First Posted: 2024-03-20
• Last Update Posted: 2024-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
70% Isopropyl Alcohol novel preoperative skin antiseptic	70% v/v Isopropyl Alcohol Surgical Solution	70% v/v Isopropyl Alcohol novel preoperative skin antisepsis preparation
2% Chlorhexidine Gluconate/70% Isopropyl Alcohol preoperative skin antiseptic	2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol	2% Chlorhexidine Gluconate/70% Isopropyl Alcohol preoperative skin antisepsis preparation

Primary Outcome Measures

Name	Time	Method
Surgical Site Infection Occurrence	Within 30 days after surgery	The primary objective is to demonstrate efficacy in surgical use through the rate of surgical site infections.
Allergic Reaction and Skin Irritation	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

Name	Time	Method
Subgroup Analysis of Rates of Surgical Site Infections	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

Trial Locations

Locations (1)

MCW/FH; 🇺🇸 Milwaukee, Wisconsin, United States