Microlyte Dressing in the Management of Wounds

Not Applicable

• Conditions: Wound Heal
• Interventions: Device: Wound Healing

• Registration Number: NCT03204851
• Lead Sponsor: Mission Health System, Asheville, NC

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-20
• Study First Submitted: 2017-06-28
• Study First Submitted QC: 2017-06-28
• Study First Posted: 2017-07-02
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-24
• Last Update Posted: 2020-02-25
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Wounds from a variety of etiologies	Wound Healing	Wounds from a variety of etiologies
Diabetic Foot Ulcers	Wound Healing	Diabetic Foot Ulcers
Venous Stasis Ulcer	Wound Healing	Venous Stasis Ulcer
Pressure Ulcers	Wound Healing	Pressure Ulcers

Primary Outcome Measures

Name	Time	Method
percentage change in wound size from initiation of Microlyte Ag treatment through 90 days or until wound closure.	90 days	Wound Healing

Trial Locations

Locations (1)

Mission Health System; 🇺🇸 Asheville, North Carolina, United States