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Effectiveness of an Antimicrobial Agent for Preoperative Skin Preparation

NCT03224299 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2021-04-23

Study results available
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Summary

Objective of this study is to compare the antimicrobial properties of an investigational agent to an active control and a negative control when applied to specific body locations. Testing will be performed according to the procedures outlined in the Food and Drug Administration Tentative Final Monograph (TFM) for Effectiveness Testing of a Patient Preoperative Skin Preparation

Conditions

  • Preoperative Skin Preparation

Interventions

DRUG

OCT - clear

Investigational Product #1: octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - clear

DRUG

OCT- tinted

Investigational product #2: octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - tinted

OTHER

ChloraPrep

Active Control: ChloraPrep® - Hi-Lite Orange® applicator

OTHER

Saline

Negative Control: sterile 0.9% saline applied with single use applicator

Sponsors & Collaborators

  • Becton, Dickinson and Company

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-21
Primary Completion
2017-08-24
Completion
2017-10-03
FDA Drug
Yes

Countries

  • United States

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 NCT03224299 on ClinicalTrials.gov