Microlyte Dressing in the Management of Wounds

Status unconfirmed · Not applicable

Conditions studied: Wound Heal

In brief

The purpose of this pilot study is to assess the efficacy of Microlyte Ag wound dressing when used in complex skin wounds. Microlyte Ag is a class-II medical device cleared by the FDA for prescription and over the counter use in humans. Primary clinical end point of study is percentage change in wound size from initiation of Microlyte Ag treatment through 90 days or until wound closure. Patient population comprises patients referred to Mission's Wound Healing and Hyperbaric Center for management of their wounds. Targeted enrollment is 100 subjects distributed into 4 study cohorts corresponding to the type of wound treated: venous stasis ulcer (20 patients); diabetic foot ulcer \[DFU\] (20 patients); pressure ulcer (20 patients); wounds of various other etiologies (40 patients).

Key facts

Study ID

NCT03204851

Run by

Mission Health System, Asheville, NC

People needed

100

Starts

2016-10-20

Expected to finish

2020-12-31

Last updated by the study team

2020-02-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Men and women ≥18 years of age, inclusive
• Venous stasis ulcer, DFU, pressure ulcer, or other wound sufficiently complex as to be referred to Clinical Investigators at Mission's Wound Care and Bariatric Center
• Patient must be competent to consent for self

You may not qualify if…

• Patients younger than 18 years of age
• Women who are pregnant or nursing
• Prisoners

Where it is running

• Mission Health System — Asheville, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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