Microlyte Dressing in the Management of Wounds (Microlyte)
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ClinicalTrials.gov Identifier: NCT03204851 |
Recruitment Status : Unknown
Verified February 2020 by Mission Health System, Asheville, NC.
Recruitment status was: Recruiting
First Posted : July 2, 2017
Last Update Posted : February 25, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Wound Heal | Device: Wound Healing | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-Label Prospective Pilot Study to Evaluate the Efficacy and Tolerability of Microlyte Ag Pre-Dressing in the Management of Complex Skin Wounds. |
Actual Study Start Date : | October 20, 2016 |
Estimated Primary Completion Date : | December 1, 2020 |
Estimated Study Completion Date : | December 31, 2020 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Venous Stasis Ulcer
Venous Stasis Ulcer
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Device: Wound Healing
Microlyte Ag is a class-II medical device cleared by the FDA for prescription and over the counter use in humans with skin wounds. |
Active Comparator: Pressure Ulcers
Pressure Ulcers
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Device: Wound Healing
Microlyte Ag is a class-II medical device cleared by the FDA for prescription and over the counter use in humans with skin wounds. |
Active Comparator: Diabetic Foot Ulcers
Diabetic Foot Ulcers
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Device: Wound Healing
Microlyte Ag is a class-II medical device cleared by the FDA for prescription and over the counter use in humans with skin wounds. |
Active Comparator: Wounds from a variety of etiologies
Wounds from a variety of etiologies
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Device: Wound Healing
Microlyte Ag is a class-II medical device cleared by the FDA for prescription and over the counter use in humans with skin wounds. |
- percentage change in wound size from initiation of Microlyte Ag treatment through 90 days or until wound closure. [ Time Frame: 90 days ]Wound Healing

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03204851
Contact: Lorinda Baker | 828-257-4744 | lorinda.baker@hcahealthcare.com | |
Contact: Ashley Boone, BS | 828-213-3961 | Ashley.boone@hcahealthcare.com |
United States, North Carolina | |
Mission Health System | Recruiting |
Asheville, North Carolina, United States, 28801 | |
Contact: Ashley Boone, BS 828-213-3961 ashley.boone@msj.org | |
Contact: Nicole Gunn, MA 828-213-7055 nicole.gunn@msj.org |
Study Chair: | William Shillinglaw, DO | Mission Health System |
Responsible Party: | Mission Health System, Asheville, NC |
ClinicalTrials.gov Identifier: | NCT03204851 |
Other Study ID Numbers: |
16-08-1608 |
First Posted: | July 2, 2017 Key Record Dates |
Last Update Posted: | February 25, 2020 |
Last Verified: | February 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Wounds and Injuries |