Efficacy Study to Evaluate Antimicrobial Effectiveness of ZuraPrep™

NCT02221232 | Terminated Phase 2

• 1 other identifier: 131112-103 (ZX-ZP-0035)
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Site Infection

Keywords

ZuraPrep; Antimicrobial; Bio-Science Laboratories; Zurex Pharma; Surgical/Patient preoperative skin preparation

Outcome Measures

Primary Outcomes (1)

• Calculations of mean log10 reductions from baseline populations

  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.

  0-24 hours post dose

Study Arms (4)

ZuraPrep Config 1

EXPERIMENTAL

Isopropyl alcohol (IPA) 70% Standard scrub time.

Drug: ZuraPrep

ZuraPrep Config 2

EXPERIMENTAL

Isopropyl alcohol (IPA) 70% Half scrub time.

Drug: ZuraPrep

ZuraPrep Vehicle

PLACEBO COMPARATOR

ZuraPrep without IPA

Drug: ZuraPrep Vehicle

ChloraPrep

ACTIVE COMPARATOR

Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%

Drug: Chloraprep

Interventions

Chloraprep DRUG

Apply topically.

Also known as: 2% chlorhexidine gluconate / 70% Isopropyl alcohol, CHG 2% / IPA 70%

ChloraPrep

ZuraPrep DRUG

Apply topically.

Also known as: Isopropyl alcohol 70%

ZuraPrep Config 1; ZuraPrep Config 2

ZuraPrep Vehicle DRUG

Apply topically.

Also known as: ZuraPrep without IPA, ZuraPrep Placebo

ZuraPrep Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zurex Pharma, Inc.: lead

Study Sites (1)

BioSciences Laboratories, Inc.

Bozeman, Montana, 59718, United States

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

chlorhexidine gluconate; 2-Propanol; Chromogranins; citrate, isopropyl alcohol, methylene blue, parabens drug combination; Ethanol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Propanols; Alcohols; Organic Chemicals; Nerve Tissue Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors

Study Officials

• Chris Beausoleil

  BioScience Laboratories, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2014
• First Posted: August 20, 2014
• Study Start: August 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: July 18, 2016

Record last verified: 2014-11

Locations

US (1)