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Clinical Evaluation of Patient Preoperative Prep

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ClinicalTrials.gov Identifier: NCT02831816
Recruitment Status : Completed
First Posted : July 13, 2016
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):
Zurex Pharma, Inc.

Brief Summary:
The objective of the study is to demonstrate the antimicrobial efficacy of the ZP Preoperative Prep on skin flora of the abdomen and inguinal regions of human subjects.

Condition or disease Intervention/treatment Phase
Surgical Skin Preparation Drug: ZP Drug: ChloraPrep Drug: ZP Vehicle Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 640 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Clinical Evaluation of ZP, A Patient Preoperative Skin Preparation
Actual Study Start Date : August 3, 2016
Actual Primary Completion Date : August 3, 2017
Actual Study Completion Date : August 3, 2017


Arm Intervention/treatment
Experimental: ZP (70% IPA)
Isopropyl alcohol (IPA) 70%
Drug: ZP
Apply topically.
Other Name: Isopropyl alcohol 70%
Active Comparator: ChloraPrep
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%
Drug: ChloraPrep
Apply topically.
Other Names:
  • CHG 2% / IPA 70%
  • Chlorhexidine gluconate 2% / Isopropyl alcohol 70%
Placebo Comparator: ZP Vehicle
ZP without IPA
Drug: ZP Vehicle
Apply topically.
Other Name: ZP without IPA



Primary Outcome Measures :
  1. Bacterial reduction [ Time Frame: 10 minutes post product application ]
    A 2-log per cm2 bacterial reduction on the abdomen region and a 3-log per cm2 reduction on the inguinal region is considered a success.


Secondary Outcome Measures :
  1. Skin Irritation [ Time Frame: 30 seconds to 6 hours ]
    Safety as assessed by Skin Irritation score (erythema, edema, rash, dryness) of 0-3.

  2. Bacterial reduction [ Time Frame: 30 seconds post product application ]
    A 2-log per cm2 bacterial reduction on the abdomen region and a 3-log per cm2 reduction on the inguinal region is considered a success.

  3. Bacterial reduction [ Time Frame: 6 hours post product application ]
    Skin flora does not return to baseline on the abdomen and inguinal region is considered a success.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects of any race.
  • Subjects in good health.
  • Minimum skin flora baseline requirements on abdomen and groin.
  • Skin free of tattoos, dermatoses, abrasions, cuts, lesions, or other skin disorder near or on the applicable test area.

Exclusion Criteria:

  • Topical or systemic antimicrobial exposure within 14 days prior to screening and treatment days, including antibiotics.
  • Subjects with a history of skin sensitivity, skin allergies, or skin cancer.
  • Subjects who are pregnant, attempting pregnancy, or nursing.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831816


Locations
United States, Montana
BioScience Laboratories, Inc.
Bozeman, Montana, United States, 59718
Sponsors and Collaborators
Zurex Pharma, Inc.

Responsible Party: Zurex Pharma, Inc.
ClinicalTrials.gov Identifier: NCT02831816     History of Changes
Other Study ID Numbers: ZX-ZP-0074 / 150316-103
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Ethanol
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Disinfectants
Dermatologic Agents