Microlyte Dressing in the Management of Wounds

Study Overview
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Brief Summary
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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).

Official Title
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An Open-Label Prospective Pilot Study to Evaluate the Efficacy and Tolerability of Microlyte Ag Pre-Dressing in the Management of Complex Skin Wounds.

Conditions
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Wound Heal

Intervention / Treatment
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* Device: Wound Healing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Venous Stasis Ulcer<br>Venous Stasis Ulcer | Device: Wound Healing<br>* Microlyte Ag is a class-II medical device cleared by the FDA for prescription and over the counter use in humans with skin wounds.<br>|
| Active Comparator: Pressure Ulcers<br>Pressure Ulcers | Device: Wound Healing<br>* Microlyte Ag is a class-II medical device cleared by the FDA for prescription and over the counter use in humans with skin wounds.<br>|
| Active Comparator: Diabetic Foot Ulcers<br>Diabetic Foot Ulcers | Device: Wound Healing<br>* Microlyte Ag is a class-II medical device cleared by the FDA for prescription and over the counter use in humans with skin wounds.<br>|
| Active Comparator: Wounds from a variety of etiologies<br>Wounds from a variety of etiologies | Device: Wound Healing<br>* Microlyte Ag is a class-II medical device cleared by the FDA for prescription and over the counter use in humans with skin wounds.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage change in wound size from initiation of Microlyte Ag treatment through 90 days or until wound closure. | Wound Healing | 90 days |