Microlyte Dressing in the Management of Wounds

Wound Heal Clinical Trial

— Microlyte  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03204851
• Other study ID #: 16-08-1608
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2016
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2020
• Source: Mission Health System, Asheville, NC
• Contact: Lorinda Baker
• Phone: 828-257-4744
• Email: lorinda.baker[@]hcahealthcare.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Wound Heal
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Mission Health System	Asheville	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Mission Health System, Asheville, NC	Imbed Biosciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage change in wound size from initiation of Microlyte Ag treatment through 90 days or until wound closure.	Wound Healing	90 days