Centennial, Colo. — February 23, 2021 — AlloSource®, one of the largest allograft providers in the U.S., creating innovative cellular and tissue products, today announced the first patients have been enrolled in its clinical study titled, A Randomized, Controlled Study to Evaluate Effectiveness of AlloWrap® Amniotic Membrane for the Reduction of Post-Operative Soft Tissue Inflammation in Two-Level Anterior Cervical Discectomy and Fusion (ACDF) Procedures.
There are an estimated 300,000 ACDF procedures performed annually in the United States. Despite the overall positive outcomes of these procedures, one potentially costly and painful complication is inflammation of the surrounding tissue, which can cause painful swallowing and/or loss of language. The primary objective of this study is to obtain evidence of the effectiveness of AlloWrap Amniotic Membrane in the reduction of soft tissue swelling in two-level ACDF procedures.
“Though I have performed many successful anterior cervical discectomy and fusion procedures, I am always looking for ways to improve patient outcomes,” said Dr. Paul Kim with The Spine Institute of San Diego. “I am looking forward to the impact AlloWrap has on helping me with my ultimate goal of relieving patient pain and returning them to a normal life.”
AlloSource’s AlloWrap is a human amniotic membrane designed to provide a biologic barrier following surgical repair in a multitude of procedures. Regardless of the surgical approach, the product is ideal for spinal procedures because when used as a surgical barrier the dual-sided design provides covering and protection from the surrounding environment to support the body’s natural ability to ease potential complications such as inflammation, scarring and adhesion. AlloWrap DS has a moist, hydrated format that is especially suitable for endoscopic and minimally invasive surgical applications, whereas AlloWrap Dry is dehydrated for precision open-surgical placement.
“Previous animal studies using AlloWrap showed anti-inflammatory response,” said Dr. Ross Wilkins, AlloSource Senior Medical Director. “AlloWrap has been used in other areas of the body for years, and this clinical study will deepen our understanding of its impact in spine applications too.”
Founded in 1994, AlloSource is a nonprofit leader in providing allografts that maximize tissue donation to help surgeons heal their patients. The company has grown into one of the largest tissue networks in the country creating more than 200 types of precise bone, skin, soft-tissue and custom-machined allografts for use in an array of life-saving and life-enhancing medical procedures. As a world leader in cell-based products, cartilage tissue for joint repair and skin allografts to help heal severe burns, AlloSource’s products bridge the proven science of allografts with the advanced technology of cells. The company is accredited by the American Association of Tissue Banks and is headquartered in Centennial, CO. For more information, please visit allosource.org