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

EARLY_PHASE1UnknownINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

June 1, 2023

Primary Completion Date

August 1, 2023

Study Completion Date

September 30, 2023

Conditions
Infectious Disease
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
All Listed Sponsors
collaborator

BioScience Laboratories, Inc.

INDUSTRY

lead

Zaycor Healthcare Corp

INDUSTRY

NCT04703335 - Pilot Clinical Trial - Comparative Study of Two Material Concentration of OD-141309 | Biotech Hunter | Biotech Hunter