CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 131 enrolled
Drug / intervention
OCT - clear +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03224299
NCT03224299Phase 2Completed
CompareCT.gov

Effectiveness of an Antimicrobial Agent for Preoperative Skin Preparation

Becton, Dickinson and Company·interventional·Posted Jul 21, 2017·Updated Apr 23, 2021

In Brief

A Phase 2 clinical trial evaluating OCT - clear, OCT- tinted, and 2 other interventions for Preoperative Skin Preparation. Completed, enrolled 131 participants across 2 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPreoperative Skin Preparation
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJul 21, 2017
Enrollment StartJun 21, 2017
Primary CompletionAug 24, 2017
Study CompletionOct 3, 2017
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 8.9 years ago

Interventions

OCT - cleardrug

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

OCT- tinteddrug

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

ChloraPrepother

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

Salineother

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