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Microlyte Dressing in the Management of Wounds (Microlyte)

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ClinicalTrials.gov Identifier: NCT03204851
Recruitment Status : Active, not recruiting
First Posted : July 2, 2017
Last Update Posted : November 7, 2018
Sponsor:
Collaborator:
Imbed Biosciences
Information provided by (Responsible Party):
Mission Health System, Asheville, NC

Study Description
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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
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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

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Arms and Interventions
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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
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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
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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
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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
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United States, North Carolina
Mission Health System
Asheville, North Carolina, United States, 28801
Sponsors and Collaborators
Mission Health System, Asheville, NC
Imbed Biosciences
Investigators
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Study Chair: William Shillinglaw, DO Mission Health System
More Information
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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: November 7, 2018
Last Verified: November 2018

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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:
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Wounds and Injuries