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Completed

NCT Number: NCT04756804

Perioperative Patient Skin Antiseptic Preparation Evaluation

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

MCW/FH

Milwaukee, Wisconsin, 53226, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

70% v/v Isopropyl Alcohol Surgical Solution

Drug

Patient preoperative skin preparation

Other names: ZuraGard

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

Drug

Patient preoperative skin preparation

Other names: ChloraPrep

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Zurex Pharma, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 16, 2021
Registry last updated
Mar 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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