Microlyte Dressing in the Management of Wounds
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/9/2018 |
| Start Date: | October 20, 2016 |
| End Date: | March 31, 2019 |
An Open-Label Prospective Pilot Study to Evaluate the Efficacy and Tolerability of Microlyte Ag Pre-Dressing in the Management of Complex Skin Wounds.
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).
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).
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients younger than 18 years of age
- Women who are pregnant or nursing
- Prisoners
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