Positive Clinical Results Shown for Integra Bilayer Wound Matrix

Integra LifeSciences Holding Corporation, a global medical technology company, announced positive clinical and economic data on Integra Bilayer Wound Matrix (IBWM) in complex lower extremity reconstruction. This data from two retrospective studies was recently published by Stephen J. Kovach, M.D., FACS, and John P. Fischer, M.D., MPH, FACS, from the University of Pennsylvania Health System, in Plastic and Reconstructive Surgery, the official journal of the American Society of Plastic Surgeons.
 
IBWM provides an environment where the body can rebuild the layers of the skin supporting the healing process. In areas of the body where range of motion is important, IBWM helps patients get back to functioning and living as they did before the wound occurred.
 
This product is part of Integra’s broader regenerative technology portfolio of collagen and amniotic products for use by clinicians in the operating room to help address the epidemic of approximately 8.2 million wounds, with an estimated cost to U.S. Medicare of up to $98.6 billion annually.¹ 
 
“These studies demonstrate our ongoing commitment to investing in clinical data and providing innovative solutions to help surgeons effectively repair and close wounds, while restoring functionality for patients,” said Robert T. Davis, Jr., executive vice president and president, Orthopedics and Tissue Technologies. “During this COVID-19 pandemic, IBWM can help address the efficiency needed in operating rooms by reducing both the operating time and costs to hospitals and patients. We have continued to provide educational opportunities to surgeons to improve the standard of care and quality of life for patients suffering from debilitating wounds.”
 
Last week, 200 surgeons worldwide attended an Integra LifeSciences webinar “Efficient & Effective Ways to Manage Lower Extremity Wounds.” During this webinar, Drs. Kovach and Fischer presented their recently published data and shared their insights and strategies to help address the efficiency of operating room time and prioritization of procedures as operating rooms start to reopen during the COVID-19 pandemic. 
 
“In complex lower extremity reconstruction, no approach is completely effective in all situations and contexts, and our recent publications highlight the key scenarios where skin substitutes can be optimally positioned for maximal clinical success,” said Fischer, a plastic surgeon and assistant professor of surgery and director of clinical research at University of Pennsylvania Health System. “Our findings identify key relative advantages with respect to operative efficiency and hospital utilization that align with current issues caused by the COVID-19 pandemic.”
 
“Lower extremity reconstruction can be challenging and costly for both the patient and health care system. Our goal is to choose an appropriate treatment algorithm, including dermal constructs, that restores function while providing economic benefits,” said Kovach, a plastic surgeon and Herndon B. Lehr endowed associate professor of surgery at the University of Pennsylvania Health System.
 
Over the last 30 years, Integra Dermal Matrices have been studied in more than 300 clinical trials and studies. They have helped nearly one million patients recover and restore functionality so they can live their lives.
 
Summary of Study Results
The first clinical publication reviews the efficacy of the Integra Bilayer Wound Matrix for lower extremity soft tissue reconstruction. With 70 percent of the wounds successfully salvaged at the 180-day timepoint, the authors were able to identify success factors across patient selection and wound types. 
 
The second publication reviewed cost and resource utilization comparing Integra Bilayer Wound Matrix, Local Tissue Rearrangement (LTR) and Free Flap (FF).  This study showed significantly longer surgery time at 85 and 408 minutes for LTR and FF respectively, compared with 50 minutes for Integra Bilayer Wound Matrix. It also reported more than double the length of stay in the hospital for both LTR and FF versus Integra Bilayer Wound Matrix. Lastly, total cost of the surgery was $53,492 for FF, $35,220 for LTR and $34,877 for Integra Bilayer Wound Matrix. Given the shorter operating time and the potential lower cost, Integra Bilayer Wound Matrix may represent an opportunity for patients, surgeons and hospitals during the current situation.
 
Reference
¹ Chandan K. Sen, Ph.D., Human Wounds and Its Burden: An Updated Compendium of Estimates, ADVANCES IN WOUND CARE, VOLUME 8, NUMBER 2