The first study, underway at Mission Health System in Asheville, NC, is an investigation of Microlyte® Matrix in complex and non-healing wounds. Mission Health is coordinating and conducting the 100-patient prospective clinical study, which will assess the efficacy of Microlyte® Matrix when used in complex skin wounds, including venous stasis ulcers, pressure ulcers, and diabetic foot ulcers. The primary objective of the study is to determine the percentage of change in the wound size when treated with Microlyte® Matrix. A secondary objective includes evaluating how long wound closure takes when using Microlyte® Matrix in the wound. Patients treated with Microlyte® Matrix are being followed for up to 12 weeks.
Microlyte® Matrix is a class II medical device which has been 510(k) cleared by the US Food and Drug Administration (FDA). It is a fully-synthetic bioresorbable wound matrix composed primarily of a polyvinyl alcohol sheet with a polymeric surface coating containing ionic and metallic silver. Microlyte® Matrix is intended for use on partial and full thickness wounds including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second-degree burns, abrasions and lacerations, donor sites and surgical wounds. Microlyte® Matrix may also be used over debrided and grafted partial thickness wounds. Microlyte® Matrix works differently than conventional silver-impregnated wound dressings and is designed to be safer and more readily adherent to the varied topography of complex wound beds where potential sources of infection can sequester themselves. Microlyte® Matrix uniquely combines bioresorbability and antimicrobial effectiveness in a fully-synthetic product—a first of its kind in the wound care space. Components of the matrix have been shown to support cell growth and vascularization to support wound healing.
Chronic non-healing ulcers are a significant medical problem and the incidence of these wounds is expected to increase as the United States population ages and diabetes becomes more prevalent. The three major subcategories include diabetic foot ulcers (DFU), venous stasis ulcers, and pressure ulcers. The major challenge in the management of open wounds is the reduction of infection causing bacteria. Standard therapies only cure approximately 30 to 50% of DFU after 3 months and approximately 50% of venous stasis ulcers. Pressure ulcers are more difficult as they are associated with immobility, malnutrition and tobacco abuse.
In addition to the chronic wound study at Mission Health, Imbed Biosciences has enrolled several other wound care centers and hospitals, and is seeking additional clinical partners to evaluate Microlyte® Matrix in other approved indications including burns and surgical applications. A nationwide patient registry will be established to document and assess the real-world use of Microlyte® Matrix, as well as economic outcome information.
“Imbed is very pleased to have a world-class healthcare system like Mission Health evaluating Microlyte® Matrix and assessing how the product can best help its patients with slow-healing and stalled wounds,” said Imbed’s President and CEO, Ankit Agarwal. “The early results seem very promising, so we are eager see the outcome of this study as well as future studies that we are planning with other clinical partners.”
Institutions interested in participating in the clinical research program should email firstname.lastname@example.org. Additional information about the study at Mission Health can be found at www.clinicaltrials.govunder identifier NCT03204851. Information about Microlyte® Matrix can be found at www.microlytematrix.com.