Thursday February 25, 2021 0 comments
CENTENNIAL -- AlloSource 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.
AlloSource said 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 said its 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, the company said.
"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."