- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02578771
Pilot Clinical Evaluation to Characterize in Vivo Effects of Topically Applied ZuraPrep & ZuraPrep Vehicle
Pilot Clinical Evaluation to Characterize the in Vivo Effects of Topically Applied ZuraPrep and ZuraPrep Vehicle
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The single investigational test article, ZuraPrep solution is being evaluated for efficacy as a preoperative skin preparation solution to demonstrate its immediate and persistent antimicrobial properties. At least 72 subjects will be randomized utilizing bilateral applications on abdomen and groin.
The primary objective of this study is to characterize the in vivo effects of the ZuraPrep test article compared to the positive reference control ChloraPrep, as well as to evaluate the ZuraPrep test vehicle to the negative control, Saline, using the newly proposed sampling intervals.
This is a randomized, paired-comparisons design where each subject will receive two of the planned treatments, one on the left side of body and one on the right. Treatments will be evaluated at 30 seconds, 10 minutes and 6 hour sampling intervals compared to baseline. Status will be calculated separately for the abdomen and groin for each side of the body.
Study duration for subjects - 3 to 4 weeks.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Virginia
-
Sterling, Virginia, United States, 20164
- Microbiotest
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy male and female volunteers, 18 years of age 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.
- Cooperative and willing to sign Consent Form and HIPAA Authorization Form.
- Have acceptable Screening Day baseline counts (CFU/cm2).
Exclusion Criteria:
- 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 prior to 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 products.
- 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. For all females of child-bearing potential (<60 years of age), a urine pregnancy test will be performed prior to treatment on Treatment Day.
- Subjects who have showered or bathed within 72 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 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
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ZuraPrep with 70% Isopropyl alcohol
Test Article ZuraPrep with 70% isopropyl alcohol (IPA) will be compared with reference positive control Chloraprep
|
Apply topically
Other Names:
Apply topically
Other Names:
|
Experimental: ZuraPrep without 70% IPA
Vehicle test article ZuraPrep without isopropyl alcohol will be compared with normal saline
|
Apply topically. 0% IPA
Other Names:
Apply topically
Other Names:
|
Active Comparator: ChloraPrep Teal Tint
Test Article ZuraPrep with 70% isopropyl alcohol will be compared with reference positive control ChloraPrep [Chlorhexidine gluconate(CHG)/IPA] Teal Tint
|
Apply topically
Other Names:
Apply topically
Other Names:
|
Placebo Comparator: Normal Saline 0.85%
Vehicle test article ZuraPrep without isopropyl alcohol will be compared with normal saline 0.85%
|
Apply topically. 0% IPA
Other Names:
Apply topically
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction of skin flora measured by Tentative Final Monograph (TFM) Proposed Amendment
Time Frame: 30 seconds
|
calculated as log-10 CFU responder rates from baseline
|
30 seconds
|
Reduction of skin flora measured by 1994 TFM
Time Frame: 10 minutes
|
calculated as log-10 CFU reductions from baseline
|
10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Skin flora measurement
Time Frame: 6 hours
|
The bacterial counts should not exceed baseline at the 6 hour sampling time
|
6 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: M. Hamid Barshir, MD, Microbiotest
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZX-ZP-0068 (MBT#865-104)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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