NCT03204851

Microlyte Dressing in the Management of Wounds

An Open-Label Prospective Pilot Study to Evaluate the Efficacy and Tolerability of Microlyte Ag Pre-Dressing in the Management of Complex Skin Wounds.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Mission Health System, Asheville, NC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Conditions

• Wound Heal

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-10-20
• Primary completion: 2020-12-01
• Completion: 2020-12-31
• First posted: 2017-07-02
• Last updated: 2020-02-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study