NCT03198169

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

2-part, Randomized, Double Blind, Prospective, Single Center, Controlled Trial to Investigate an Antimicrobial Skin and Wound Cleanser and an Antimicrobial Barrier Film Dressing on the Rates of Healing for Chronic Wounds

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Atteris Healthcare, LLC · Industry
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Part 1 of this study will involve 5 patients with qualified chronic wounds which will receive active treatment with both the Atteris Antimicrobial Skin and Wound Cleanser (AWC) and the Atteris Antimicrobial Barrier Film Dressing (ABFD) for a 6-week period with a 12 week follow-up in order to optimize the final study application protocols. Part 2 of this study is a randomized, double blind, 2 by 2 factorial, controlled study comparing the AWC and/or the ABFD with 100 research subjects and n=25 subjects per cell. Patients will be randomized to receive either active AWC and active ABFD, or active AWD and placebo ABFD, or placebo AWC and active ABFC, or AWC placebo and ABFD placebo in addition to standard of care (SOC). The active AWC active ABFD versus AWC placebo ABFD placebo statistical contrast will be of most importance and the clinical expectation is wounds treated with the active forms of these products will heal faster than wounds treated with double placebo and this will additionally provide data to power a future definitive study to compare the healing potential of the two therapeutic modalities (AWC, ABFD).

Conditions

• Chronic Wounds

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-07-25
• Primary completion: 2017-09-30
• Completion: 2017-09-30
• First posted: 2017-06-26
• Last updated: 2018-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study