Efficacy Study to Evaluate Antimicrobial Effectiveness of ZuraPrep™ (ZX-ZP-0055)

NCT02296645 | Completed Phase 2

• 1 other identifier: ZX-ZP-0055 (MBT# 865-101)
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, paired-comparisons design where each subject receives two of the planned treatments.

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

• Reduction of skin flora

  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

Study Arms (2)

ZuraPrep

EXPERIMENTAL

Isopropyl alcohol (IPA) (70%)

Drug: ZuraPrep

ChloraPrep

ACTIVE COMPARATOR

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

Drug: ChloraPrep

Interventions

ZuraPrep DRUG

Apply topically.

Also known as: Isopropyl alcohol 70%

ZuraPrep

ChloraPrep DRUG

Apply topically.

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

ChloraPrep

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zurex Pharma, Inc.: lead

Study Sites (1)

MicroBioTest Laboratories

Sterling, Virginia, 20164, United States

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

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

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• M. Hamid Bashir, MD

  MicroBioTest, Division of Microbac Laboratories, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2014
• First Posted: November 20, 2014
• Study Start: November 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: July 14, 2016

Record last verified: 2015-03

Locations

US (1)