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Pilot Clinical Trial - Comparative Study of Two Material Concentration of OD-141309

NCT04703335 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2022-02-11

No results posted yet for this study

Summary

A sufficient number of subjects will be entered into testing to complete 42 subjects per each of the 2 test and 2 control configurations. A total of 84 subjects, testing bi-laterally (168 abdomen and groin sites in total completed, 42 abdomen and groin sites per each test and control material) will be evaluated using the standardized ASTM E1173 test method. Following a 14-day restriction period, subjects will be sampled for baseline, 10 minutes, 6 hours, and 24 hours post application (subjects will not be sequestered) for microbial reduction evaluations. Test day baseline criteria will be set at: abdomen: ≥ 3.0 log10 CFU/cm2, and groin: ≥ 5.0 log10 CFU/cm2.

Conditions

Interventions

DRUG

Antimicrobial efficacy of gel ZHCK4 as a patient preoperative skin preparation

Evaluate the antimicrobial efficacy of two concentrations of one patient preoperative skin preparation product compared to a positive control (2.0% chlorhexidine gluconate) and negative control (physiological saline 0.9% solution). Following a 14-day restriction period, subjects will be sampled for baseline, 10-minutes, 6-hours, and 24-hours microbial reduction evaluations post-product application. Subjects will not be sequestered for the 6-hour or 24-hour evaluations. Test day baseline criteria will be set at: abdomen: ≥ 3.0 log10 CFU/cm2, and inguen: ≥ 5.0 log10 CFU/cm2.

Sponsors & Collaborators

  • BioScience Laboratories, Inc.

    collaborator INDUSTRY

  • Zaycor Healthcare Corp

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2023-08-01
Completion
2023-09-30
FDA Drug
Yes

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04703335 on ClinicalTrials.gov