- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02296645
Efficacy Study to Evaluate Antimicrobial Effectiveness of ZuraPrep™ (ZX-ZP-0055)
July 12, 2016 updated by: Zurex Pharma, Inc.
A Pilot Clinical Evaluation of the Antimicrobial Effectiveness of Topically Applied ZuraPrep™
This is a randomized, paired-comparisons design where each subject receives two of the planned treatments.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
ZuraPrep is being evaluated for safety and efficacy as a preoperative skin preparation against the Tentative Final Monograph (TFM) 10-minute end point recently revised by the FDA for the lower bound of a 95% confidence interval whereas there must be specific reductions of normal flora in the abdomen and groin areas.
A positive control will be evaluated as well.
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
-
Sterling, Virginia, United States, 20164
- MicroBioTest Laboratories
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Subjects to whom all of these conditions apply will be eligible for enrollment in this study:
- Males and/or females, at least 18 years or older. Are in good general health.
- Have skin within 6 inches of the test sites that is free of tattoos, dermatoses, abrasions, cuts, lesions or other skin disorders.
- Cooperative and willing to follow Subject Instructions (Appendix 14.6).
- Cooperative and willing to sign Consent Form and HIPAA Authorization Form.
- Have Screening Day baseline counts of at least 1.3 x 103 CFU/cm2 per abdominal site (left and right) and 1.0 x 105 CFU/cm2 per groin site (left and right). For replacement subjects, have Screening Day baseline counts of at least 1.3 x 103 CFU/cm2 per abdominal site (left and right) and/or 1.0 x 105 CFU/cm2 per groin site (left and right).
Exclusion Criteria:
Subjects to whom any of these conditions apply will be excluded from this study:
- Topical or systemic antimicrobial exposure within 14 days prior to Screening Day. Restrictions include, but are not limited to antimicrobial soaps, antiperspirants/deodorants, shampoos, lotions, perfumes, after shaves, colognes, and topical or systemic antibiotics.
- Swimming in chemically treated pools or bathing in hot tubs, spas and whirlpools within 14 days prior to Screening Day.
- Use of tanning beds, hot waxes, or depilatories, including shaving (in the applicable test areas) within 14 days prior to Screening Day.
- Contact with solvents, acids, bases, fabric softener-treated clothing or other household chemicals in the applicable test areas within 14 days of the Screening Day. Subjects who have a history of sensitivity to natural rubber latex, adhesive skin products (e.g., Band-Aids, medical tapes), isopropyl alcohol, citric acid, methylene blue, methylparaben, propylparaben, or chlorhexidine gluconate chlorhexidine gluconate products.
- Subjects who have a history of diabetes.
- Subjects who have a history of skin allergies.
- Subjects who have a history of skin cancer within 6 inches of the applicable test areas.
- Subjects who are pregnant, attempting pregnancy or nursing.
- Subjects who have showered or bathed within 48 hours of the Screening Day or Treatment Day (sponge baths may be taken, however, the lower abdomen and upper thigh region must be avoided).
- Subjects who receive an irritation score of 1 for any individual skin condition prior to the Screening Day baseline or Treatment Day baseline sample collection.
- Participation in another clinical trial in the 30 days prior to Test Day of this study (treatment with test materials in this study), or be currently enrolled in another clinical trial, or has previously participated in this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ZuraPrep
Isopropyl alcohol (IPA) (70%)
|
Apply topically.
Other Names:
|
Active Comparator: ChloraPrep
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%
|
Apply topically.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction of skin flora
Time Frame: 10 minutes
|
The primary measure of antimicrobial efficacy is the log10 reduction of skin flora on the abdominal and groin sites 10 minutes following application of the study treatments relative to the Treatment Day baseline log10 counts.
|
10 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: M. Hamid Bashir, MD, MicroBioTest, Division of Microbac Laboratories, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2014
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
November 18, 2014
First Submitted That Met QC Criteria
November 18, 2014
First Posted (Estimate)
November 20, 2014
Study Record Updates
Last Update Posted (Estimate)
July 14, 2016
Last Update Submitted That Met QC Criteria
July 12, 2016
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZX-ZP-0055 (MBT# 865-101)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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