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Efficacy Study to Evaluate Antimicrobial Effectiveness of ZuraPrep™ (ZX-ZP-0035)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02221232
Recruitment Status : Terminated (To assess product performance (test and reference products), move into further testing.)
First Posted : August 20, 2014
Last Update Posted : July 18, 2016
Sponsor:
Information provided by (Responsible Party):
Zurex Pharma, Inc.

Brief Summary:
The purpose of this pilot study is to evaluate antimicrobial properties of a single test product, a vehicle product and a reference product applied in two different areas when used as a patient preoperative skin preparation.

Condition or disease Intervention/treatment Phase
Surgical Site Infection Drug: Chloraprep Drug: ZuraPrep Drug: ZuraPrep Vehicle Phase 2

Detailed Description:
This is an open label pilot study to evaluate antimicrobial properties of a single test product, a vehicle product and a reference product applied bilaterally to the skin of the abdomen and the inguina. Testing will be performed according to FDA TFM for Effectiveness Testing of a Patient Preoperative Skin Preparation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: A Pilot Clinical Evaluation of the Antimicrobial Effectiveness of Topically Applied ZuraPrep™
Study Start Date : August 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: ZuraPrep Config 1
Isopropyl alcohol (IPA) 70% Standard scrub time.
Drug: ZuraPrep
Apply topically.
Other Name: Isopropyl alcohol 70%

Experimental: ZuraPrep Config 2
Isopropyl alcohol (IPA) 70% Half scrub time.
Drug: ZuraPrep
Apply topically.
Other Name: Isopropyl alcohol 70%

Placebo Comparator: ZuraPrep Vehicle
ZuraPrep without IPA
Drug: ZuraPrep Vehicle
Apply topically.
Other Names:
  • ZuraPrep without IPA
  • ZuraPrep Placebo

Active Comparator: ChloraPrep
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%
Drug: Chloraprep
Apply topically.
Other Names:
  • 2% chlorhexidine gluconate / 70% Isopropyl alcohol
  • CHG 2% / IPA 70%




Primary Outcome Measures :
  1. Calculations of mean log10 reductions from baseline populations [ Time Frame: 0-24 hours post dose ]
    Antimicrobial efficacy will be evaluated based upon calculation of mean log10 reductions from baseline populations by subtracting the log10 number of viable microorganisms recovered at each post-product application sample from the log10 number of viable microorganisms recovered in the baseline samples. The performance criteria are mean reductions in microbial flora of ≥2 log10 per square cm on skin of the abdomen and ≥3 log10 per square cm on skin of the inguen.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects may be of either sex, at least 18 years of age and of any race.
  • Subjects must be in good general health, as evidenced by the Subject Confidential Information and Acceptance Criteria
  • Subjects must read and sign an Informed Consent Form, Authorization to Use and Disclose Protected Health Information Form, and List of Restricted Products

Exclusion Criteria:

  • Exposure of test sites to antimicrobial agents, medicated soaps, medicated shampoos, or medicated lotions, use of biocide-treated pools or hot tubs, use of tanning beds, or sunbathing during the 14-day pre-test conditioning period or during the test period.
  • Use of topical or systemic antimicrobials, antibiotics, or steroids (other than hormones for contraception or post-menopausal indications), or any other product known to affect the normal microbial flora of the skin during the 14-day pre-test conditioning period or during the test period.
  • Exposure of the test sites to strong detergents, solvents, or other irritants during the 14-day pre-test conditioning period or during the test period.
  • Known allergies to vinyl, latex (rubber), alcohols, metals, inks, or tape adhesives, or to common antibacterial agents found in soaps, lotions, or ointments, particularly chlorhexidine gluconate (CHG), citric acid, methylene blue, methylparaben, propylparaben, or isopropyl alcohol.
  • A medical diagnosis of a physical condition, such as a current or recent severe illness, asthma, diabetes, hepatitis, an organ transplant, mitral valve prolapse, congenital heart disease, internal prostheses, or any immunocompromised conditions such as AIDS (or HIV positive).
  • Subjects must be unable to become pregnant, or willing to use an acceptable method of contraception to prevent pregnancy, if female of child-bearing potential.

Inability to become pregnant would include subjects who are:

  • Male
  • Females unable to become pregnant (i.e., postmenopausal for at least 1 year or surgically sterile due to hysterectomy, bilateral oophorectomy, uterine ablation, or bilateral tubal ligation)
  • Females of child-bearing potential but using acceptable methods of contraception, including one of the following methods that have been used for at least 2 weeks prior to Treatment Day Visit.

Acceptable methods of contraception include one of the following methods:

  • Systemic birth control (the same type of birth control for at least 3 months prior to entering the study and continuation of this type of birth control throughout the study)
  • Double barrier methods (condom with spermicide or diaphragm with spermicide)
  • IUD
  • Vasectomized partner; or
  • Abstinence from sexual intercourse

    • Any large tattoos, scars, active skin rashes, or breaks in the skin of the test sites.
    • Dermatoses, cuts, lesions, or other skin disorders on or around the test sites
    • A currently active skin disease or inflammatory skin condition (e.g., contact dermatitis) that, in the opinion of the Consulting Physician or Principal Investigator, would compromise subject safety or study integrity.
    • Showering, bathing, or swimming within the 72 hour period prior to Baseline Day, the first Test Day, and throughout the test period.
    • Participation in another clinical study in the past 30 days or current participation in another clinical study.
    • Any medical condition or use of any medications that, in the opinion of the Medical Expert/Consulting Physician or Principal Investigator, should preclude participation.
    • Unwillingness to fulfill the performance requirements of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02221232


Locations
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United States, Montana
BioSciences Laboratories, Inc.
Bozeman, Montana, United States, 59718
Sponsors and Collaborators
Zurex Pharma, Inc.
Investigators
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Principal Investigator: Chris Beausoleil BIOSCIENCE LABORATORIES, INC.
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Responsible Party: Zurex Pharma, Inc.
ClinicalTrials.gov Identifier: NCT02221232    
Other Study ID Numbers: 131112-103 (ZX-ZP-0035)
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: July 18, 2016
Last Verified: November 2014
Keywords provided by Zurex Pharma, Inc.:
ZuraPrep
Antimicrobial
Bio-Science Laboratories
Zurex Pharma
Surgical/Patient preoperative skin preparation
Additional relevant MeSH terms:
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Surgical Wound Infection
Wound Infection
Infection
Postoperative Complications
Pathologic Processes
Ethanol
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Disinfectants
Dermatologic Agents