NEWPORT NEWS, Va., Nov. 4, 2016 /PRNewswire/ -- Soluble Systems, LLC announces the Palmetto LCD now includes coverage of TheraSkin® over partial and/or full-thickness ulcers involving tendon, muscle, joint capsule or exhibiting exposed bone or sinus tracts, with a clean granular base. This is significant treatment option for the tens of thousands of Medicare patients with chronic wounds in North Carolina, South Carolina, Virginia and West Virginia.
This closely follows a breakthrough, first of its kind published study confirming TheraSkin®'s effectiveness in healing complex and difficult chronic wounds of significant size (mean size = 16 cm2) with exposed muscle, tendon and bone. This study was published in the April edition of WOUNDS, a peer reviewed indexed journal, dedicated to physicians with a circulation of more than 20,000 wound care professionals.
These lower extremity wounds are among the most difficult to heal. There has been little research in this area. Estimates range as high as 2% of the adult population may have lower extremity wounds. The causative factors are mostly related to venous etiology and the increasing prevalence of diabetes mellitus. Left unchecked, many of these will lead to amputation. An estimated 30 million people in the US have diabetes, and there are reports that as many as 75,000 amputations per year are preformed causing an annual spend for care as high as $58 billion.
The peer reviewed study was published in the April edition of WOUNDS and discussed at the Spring SAWC.
- In the study, 93.3% of the complex and challenging wounds healed in an average of 133 days.
- From the initial graft application granulation tissue was present in the wound bed in an average of 36 days.
- Wounds required an average of two grafts. The study provided further documentation to the clinical effectiveness of TheraSkin® in some of the most hard-to-heal wounds. This also reinforces the cost effectiveness of TheraSkin® from a health economic view point.
This study further confirms results of other clinical trials for TheraSkin® as well as results on tens of thousands of patients requiring help healing chronic wounds head to toe. "TheraSkin® provides the complete value model in advanced wound care – unsurpassed chronic wound healing even in the most challenging wounds such as over exposed tendon, muscle and bone. The clinical effectiveness is balanced in the value model by favorable reimbursement and probably the most cost effective major product in advanced wound care," states Allan Staley, CEO of Soluble Systems.
The published study in WOUNDS is from the University of Pittsburgh Medical Center, Pittsburgh, Pa; and the Washington Health System, Washington Pa. The study was conducted by Thomas C. Wilson, DPM, Jessica A. Wilson, DPM, Brandon Crim, DPM and Nicholas J. Lowery DPM.
About TheraSkin®: TheraSkin® is one of the fastest growing products in the advanced wound care market. It is a biologically active cryopreserved human skin allograft for chronic wounds. It has a fully developed extracellular matrix (ECM) and living cells that provide an "at ready" supply of human growth factors, cytokines and collagen to jumpstart the wound healing process. TheraSkin® not only provides necessary growth factors and cytokines to treat chronic wounds, it also provides a large quantity of essential types of human collagens in appropriate ratios, to support healing. This allows TheraSkin® to also be used on more severe and complex wounds with exposed bone, tendon, joint capsule or muscle.
TheraSkin is a registered trademark of Soluble Systems, LLC.
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SOURCE Soluble Systems, LLC