Microlyte Dressing in the Management of Wounds

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-20

Study Completion Date

2020-12-31

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).

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Detailed Description

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Conditions

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Wound Heal

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

* 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