Microlyte Dressing in the Management of Wounds (Microlyte)

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ClinicalTrials.gov Identifier: NCT03204851

Recruitment Status : Recruiting

First Posted : July 2, 2017

Last Update Posted : March 21, 2018

See Contacts and Locations

Sponsor:

Collaborator:

Imbed Biosciences

Information provided by (Responsible Party):

Mission Health System, Asheville, NC

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Wound Heal	Device: Wound Healing	Not Applicable

Study Design


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 31, 2018
Estimated Study Completion Date :	March 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Wounds and Injuries

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Venous Stasis Ulcer Venous Stasis Ulcer	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	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	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	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.

Outcome Measures

Primary Outcome Measures :

percentage change in wound size from initiation of Microlyte Ag treatment through 90 days or until wound closure. [ Time Frame: 90 days ]
Wound Healing

Eligibility Criteria

Information from the National Library of Medicine

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

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

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

Contacts


Contact: Tracy Nanney, RN	828-213-5593	Tracy.nanney@msj.org
Contact: Ashley Boone, BS	828-213-3961	Ashley.boone@msj.org

Locations


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

Sponsors and Collaborators

Mission Health System, Asheville, NC

Imbed Biosciences

Investigators


Study Chair:	William Shillinglaw, DO	Mission Health System

More Information


Responsible Party:	Mission Health System, Asheville, NC
ClinicalTrials.gov Identifier:	NCT03204851 History of Changes
Other Study ID Numbers:	16-08-1608
First Posted:	July 2, 2017 Key Record Dates
Last Update Posted:	March 21, 2018
Last Verified:	March 2018


Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		Yes
Device Product Not Approved or Cleared by U.S. FDA:		No
Pediatric Postmarket Surveillance of a Device Product:		No

Additional relevant MeSH terms:


Wounds and Injuries

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