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Pilot Evaluation of Two Test Materials With a Positive Control When Used as a Patient Preoperative Skin Preparation

NCT03861780 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2021-10-22

Study results available
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Summary

Comparative Study of Antimicrobial Effectiveness Evaluation of 26ml Project X, 5.1ml Project X and Prevantics Maxi Swabstick following ASTM E1173 - Standard Test Method for Evaluation of Preoperative, Precatheterization, or Preinjection Skin Preparations, ASTM International, West Conshohocken, Pennsylvania, 2015

Conditions

  • Bacteria Microflora Reduction

Interventions

DRUG

Project X 26ml

Application of antiseptic drug to the inguinal and abdomen areas of the subjects

DRUG

Project X 5.1ml

Application of antiseptic drug to the inguinal and abdomen areas of the subjects

DRUG

Prevantics Maxi Swabstick

Application of antiseptic drug to the inguinal and abdomen areas of the subjects

Sponsors & Collaborators

  • Professional Disposables International, Inc.

    lead INDUSTRY

Principal Investigators

  • Collette Duley · BioScience Laboratories, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-02
Primary Completion
2019-06-06
Completion
2019-06-06
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 NCT03861780 on ClinicalTrials.gov