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Pilot Clinical Evaluation to Characterize in Vivo Effects of Topically Applied ZuraPrep & ZuraPrep Vehicle

Primary Purpose

Surgical Site Infection

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ZuraPrep with 70% IPA
ZuraPrep without 70% IPA
ChloraPrep CHG/IPA Teal Tint
Normal Saline
Sponsored by
Zurex Pharma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Surgical Site Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • MicroBioTest

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

ZuraPrep with 70% Isopropyl alcohol

ZuraPrep without 70% IPA

ChloraPrep Teal Tint

Normal Saline 0.85%

Arm Description

Test Article ZuraPrep with 70% isopropyl alcohol (IPA) will be compared with reference positive control Chloraprep

Vehicle test article ZuraPrep without isopropyl alcohol will be compared with normal saline

Test Article ZuraPrep with 70% isopropyl alcohol will be compared with reference positive control ChloraPrep [Chlorhexidine gluconate(CHG)/IPA] Teal Tint

Vehicle test article ZuraPrep without isopropyl alcohol will be compared with normal saline 0.85%

Outcomes

Primary Outcome Measures

Reduction of skin flora measured by Tentative Final Monograph (TFM) Proposed Amendment
calculated as log-10 CFU responder rates from baseline
Reduction of skin flora measured by 1994 TFM
calculated as log-10 CFU reductions from baseline

Secondary Outcome Measures

Skin flora measurement
The bacterial counts should not exceed baseline at the 6 hour sampling time

Full Information

First Posted
October 8, 2015
Last Updated
July 13, 2017
Sponsor
Zurex Pharma, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02578771
Brief Title
Pilot Clinical Evaluation to Characterize in Vivo Effects of Topically Applied ZuraPrep & ZuraPrep Vehicle
Official Title
Pilot Clinical Evaluation to Characterize the in Vivo Effects of Topically Applied ZuraPrep and ZuraPrep Vehicle
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zurex Pharma, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
ZuraPrep 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. ZuraPrep active product and reference positive control will be compared; ZuraPrep non-active and negative control will be compared. Each subject will receive two of the planned treatments, one on the left side of body and one of the right. Study duration for subjects - 3 to 4 weeks.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection

7. Study Design

Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ZuraPrep with 70% Isopropyl alcohol
Arm Type
Experimental
Arm Description
Test Article ZuraPrep with 70% isopropyl alcohol (IPA) will be compared with reference positive control Chloraprep
Arm Title
ZuraPrep without 70% IPA
Arm Type
Experimental
Arm Description
Vehicle test article ZuraPrep without isopropyl alcohol will be compared with normal saline
Arm Title
ChloraPrep Teal Tint
Arm Type
Active Comparator
Arm Description
Test Article ZuraPrep with 70% isopropyl alcohol will be compared with reference positive control ChloraPrep [Chlorhexidine gluconate(CHG)/IPA] Teal Tint
Arm Title
Normal Saline 0.85%
Arm Type
Placebo Comparator
Arm Description
Vehicle test article ZuraPrep without isopropyl alcohol will be compared with normal saline 0.85%
Intervention Type
Drug
Intervention Name(s)
ZuraPrep with 70% IPA
Other Intervention Name(s)
70% IPA
Intervention Description
Apply topically
Intervention Type
Drug
Intervention Name(s)
ZuraPrep without 70% IPA
Other Intervention Name(s)
ZuraPrep Vehicle
Intervention Description
Apply topically. 0% IPA
Intervention Type
Drug
Intervention Name(s)
ChloraPrep CHG/IPA Teal Tint
Other Intervention Name(s)
CHG 2% / IPA 70%
Intervention Description
Apply topically
Intervention Type
Other
Intervention Name(s)
Normal Saline
Other Intervention Name(s)
0.85% Sodium Chloride (NaCl)
Intervention Description
Apply topically
Primary Outcome Measure Information:
Title
Reduction of skin flora measured by Tentative Final Monograph (TFM) Proposed Amendment
Description
calculated as log-10 CFU responder rates from baseline
Time Frame
30 seconds
Title
Reduction of skin flora measured by 1994 TFM
Description
calculated as log-10 CFU reductions from baseline
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Skin flora measurement
Description
The bacterial counts should not exceed baseline at the 6 hour sampling time
Time Frame
6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M. Hamid Barshir, MD
Organizational Affiliation
MicroBioTest
Official's Role
Principal Investigator
Facility Information:
Facility Name
MicroBioTest
City
Sterling
State/Province
Virginia
ZIP/Postal Code
20164
Country
United States

12. IPD Sharing Statement

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Pilot Clinical Evaluation to Characterize in Vivo Effects of Topically Applied ZuraPrep & ZuraPrep Vehicle

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