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A Study to Investigate Two Atteris Antimicrobial Products on Chronic Wound Healing.

NCT03198169 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2018-04-06

No results posted yet for this study

Summary

This is a 2-part pilot study to determine the clinical effectiveness of two new antimicrobial products on the complete healing of chronic wounds.

Conditions

  • Chronic Wounds

Interventions

DEVICE

Atteris Antimicrobial Skin and Wound Cleanser

Wounds will be cleansed with either the experimental wound cleanser or a placebo and will then be covered with standard of care wound dressings.

DEVICE

Atteris Antimicrobial Barrier Film Dressing

Wounds will be covered with either the experimental barrier film dressing or a placebo and will then be covered with standard of care wound dressings.

Sponsors & Collaborators

  • Rochal Industries LLC

    collaborator INDUSTRY

  • Atteris Healthcare, LLC

    lead INDUSTRY

Principal Investigators

  • Jeffrey Niezgoda, MD, FACHM, MAPWCA, CHWS · AZH Wound & Hyperbaric Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-25
Primary Completion
2017-09-30
Completion
2017-09-30
FDA Device
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 NCT03198169 on ClinicalTrials.gov