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Evaluation of the Antimicrobial Effectiveness of CHG/IPA

NCT04035161 · Status: COMPLETED · Type: INTERVENTIONAL · Enrollment: 1935

Last updated 2021-08-17

Study results available
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Summary

This single site study is a randomized, controlled, partially-blinded design enrolling a minimum of 516 healthy volunteers, where each subject will receive two of the planned study products on the product application sites of the abdomen and/or groin.

Conditions

  • Microbial Colonization

Interventions

COMBINATION_PRODUCT

Investigational Product

2%(w/v) Chlorhexidine in 70%(v/v) Isopropyl skin preparation

OTHER

Reference Standard

60% (v/v) 1-propanol skin preparation

COMBINATION_PRODUCT

Active Comparator

ChloraPrep® SEPP® skin preparation

OTHER

Negative Control

0.9% Normal Saline skin preparation

Sponsors & Collaborators

  • Becton, Dickinson and Company

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-17
Primary Completion
2019-12-24
Completion
2019-12-24

Countries

  • Romania

Study Locations

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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 NCT04035161 on ClinicalTrials.gov