Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Microlyte Dressing in the Management of Wounds (Microlyte)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03204851
Recruitment Status : Completed
First Posted : July 2, 2017
Last Update Posted : August 21, 2019
Sponsor:
Collaborator:
Imbed Biosciences
Information provided by (Responsible Party):
Mission Health System, Asheville, NC

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 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
Actual Primary Completion Date : December 1, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Locations
Layout table for location information
United States, North Carolina
Mission Health System
Asheville, North Carolina, United States, 28801
Sponsors and Collaborators
Mission Health System, Asheville, NC
Imbed Biosciences
Investigators
Layout table for investigator information
Study Chair: William Shillinglaw, DO Mission Health System
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal 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: August 21, 2019
Last Verified: August 2019

Layout table for additional information
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:
Layout table for MeSH terms
Wounds and Injuries