Microlyte Dressing in the Management of Wounds

Mission Health System, Asheville, NC

Status: Unknown

Conditions: Wound Heal

Treatments: Device: Wound Healing

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03204851

16-08-1608

Details and patient eligibility

About

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).

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 4 patient groups

Venous Stasis Ulcer

Active Comparator group

Description:

Venous Stasis Ulcer

Treatment:

Device: Wound Healing

Pressure Ulcers

Active Comparator group

Description:

Pressure Ulcers

Treatment:

Device: Wound Healing

Diabetic Foot Ulcers

Active Comparator group

Description:

Diabetic Foot Ulcers

Treatment:

Device: Wound Healing

Wounds from a variety of etiologies

Active Comparator group

Description:

Wounds from a variety of etiologies

Treatment:

Device: Wound Healing