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
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).
Condition:
Chronic Wounds
Treatment:
Atteris Antimicrobial Skin and Wound Cleanser
Start Date:
July 25, 2017
Sponsor:
Atteris Healthcare, LLC
For More Information:
https://clinicaltrials.gov/show/NCT03198169