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Perioperative Patient Skin Antiseptic Preparation Evaluation

Primary Purpose

Surgical Site Infection

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
70% v/v Isopropyl Alcohol Surgical Solution
2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol
Sponsored by
Zurex Pharma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Site Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • MCW/FH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

70% Isopropyl Alcohol novel preoperative skin antiseptic

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

Arm Description

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

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

Outcomes

Primary Outcome Measures

Surgical Site infection occurrence
The primary objective is to demonstrate efficacy in surgical use through the rate of surgical site infections.
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.

Secondary Outcome Measures

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.
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

Full Information

First Posted
February 11, 2021
Last Updated
January 17, 2023
Sponsor
Zurex Pharma, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04756804
Brief Title
Perioperative Patient Skin Antiseptic Preparation Evaluation
Official Title
A Randomized, Controlled Clinical Trial Evaluating A Novel Perioperative Patient Skin Antiseptic Preparation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 21, 2021 (Actual)
Primary Completion Date
September 29, 2022 (Actual)
Study Completion Date
September 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zurex Pharma, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
70% Isopropyl Alcohol novel preoperative skin antiseptic
Arm Type
Experimental
Arm Description
70% v/v Isopropyl Alcohol novel preoperative skin antisepsis preparation
Arm Title
2% Chlorhexidine Gluconate/70% Isopropyl Alcohol preoperative skin antiseptic
Arm Type
Active Comparator
Arm Description
2% Chlorhexidine Gluconate/70% Isopropyl Alcohol preoperative skin antisepsis preparation
Intervention Type
Drug
Intervention Name(s)
70% v/v Isopropyl Alcohol Surgical Solution
Other Intervention Name(s)
ZuraGard
Intervention Description
Patient preoperative skin preparation
Intervention Type
Drug
Intervention Name(s)
2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol
Other Intervention Name(s)
ChloraPrep
Intervention Description
Patient preoperative skin preparation
Primary Outcome Measure Information:
Title
Surgical Site infection occurrence
Description
The primary objective is to demonstrate efficacy in surgical use through the rate of surgical site infections.
Time Frame
Within 30 days after surgery
Title
Allergic reaction and skin irritation
Description
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.
Time Frame
Within 30 days after surgery
Secondary Outcome Measure Information:
Title
Subgroup analysis of rates of surgical site infections
Description
Surgical site infection rates by different infection types classified as superficial incisional infection, deep incisional infection, or organ-space infection.
Time Frame
Within 30 days after surgery
Title
Subgroup analysis of rates of surgical site infections
Description
Surgical site infection rates by type of surgery including clean (class I wound) or clean-contaminated (class II wounds) surgeries
Time Frame
Within 30 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph P Hart, MD, FACS, DFSVS
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
MCW/FH
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

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Perioperative Patient Skin Antiseptic Preparation Evaluation

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