Study: DermACELL® demonstrates superior clinical outcomes compared to AlloDerm® in breast reconstruction

Peer-reviewed "50/50 Study" shows zero incidence of Red Breast Syndrome and shorter drain removal timeframe for Dermacell

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LifeNet Health

Jan 10, 2017, 11:19 ET

VIRGINIA BEACH, Va., Jan. 10, 2017 /PRNewswire-USNewswire/ -- LifeNet Health's Dermacell acellular dermal matrix (ADM) demonstrated statistically significant improvements compared to AlloDerm Ready-To-Use (RTU) in both the incidence of Red Breast Syndrome and time to drain removal among breast reconstruction patients, according to the results of a study published by the journal Plastic & Reconstructive Surgery.

The retrospective study, "Comparison of Different Acellular Dermal Matrix (ADM) in Breast Reconstruction: The 50/50 Study¹," compared clinical outcomes between Dermacell and AlloDerm RTU in breast reconstruction — the most recent empirical study to directly compare the two grafts. Fifty-eight patients underwent reconstruction procedures using either Dermacell (30 patients, 50 breasts) or AlloDerm RTU (28 patients, 50 breasts). The same surgeon performed all reconstructions. Differences in the patients' average age, Body Mass Index, percent of patients having neo-adjuvant/adjuvant chemotherapy or breast irradiation, and numbers of therapeutic and prophylactic mastectomies between the two patient groups was not statistically significant.

Complications in both groups were recorded for 90 days post reconstruction. The authors reported that, compared to the AlloDerm group, patients in the Dermacell group showed statistically significant improvement in the incidence of Red Breast Syndrome — with zero cases reported among Dermacell recipients compared to 13 for AlloDerm RTU — and needed fewer days before drain removal (15.8 days versus 20.6). Additionally, the authors noted no significant difference in terms of seroma, hematoma, delayed healing, infection, flap necrosis, and explantation.

"The introduction of superior biomaterials like Dermacell provides reconstructive surgeons with the tools needed to perform cutting edge breast reconstruction in a safe and reproducible way," said Troy Pittman, MD, lead investigator and author of the study. "The elimination of 'red breast' and faster incorporation minimizes complications and ultimately leads to faster recovery for the patients."

Dermacell, which is processed by LifeNet Health^® and distributed by NOVADAQ^® Technologies, Inc., is a technologically advanced ADM designed for post-mastectomy breast reconstruction and for treatment of diabetic foot ulcers and chronic wounds. These allograft implants are processed utilizing Matracell^® and Preservon^®, two of LifeNet Health's patented and validated technologies.

"LifeNet Health's processing technology is what differentiates our allografts," said LifeNet Health President and CEO Rony Thomas. "The data in Dr. Pittman's study clearly supports the fact that we have a technologically advanced, superior process."

In Dec. 2014, NOVADAQ and LifeNet Health forged a multi-year agreement making NOVADAQ the exclusive worldwide distributor of Dermacell for wound management and breast reconstruction.

About LifeNet Health
LifeNet Health helps save lives, restore health, and give hope to thousands each year. It is the world's most trusted provider of transplant solutions — from organ procurement to bio-implants and cellular therapies — and a leader in regenerative medicine, while always honoring the donors and healthcare professionals who enable healing. For more information about LifeNet Health, go to www.LifeNetHealth.org.

About NOVADAQ Technologies, Inc.
NOVADAQ (NASDAQ:NVDQ; TSX:NDQ), enables physicians with point-of-care imaging solutions that provide real-time clinically significant and actionable information to improve care quality and lower healthcare costs. Using NOVADAQ's SPY fluorescence imaging technology, physicians can personalize therapy and achieve optimal results through the precise visualization of blood flow in vessels, micro-vessels, tissue perfusion and critical anatomical structures during the course of treatment. SPY technology enables the delivery of personalized therapies and the achievement of the optimal results for each individual patient. More than 230 peer-reviewed publications demonstrate that the use of SPY technology will reduce post-procedure complication rates and the cost of care for a broad variety of surgical treatments for cancer, cardiovascular diseases and other conditions, helping to ensure that patients benefit from the very best possible treatment and outcome. For more information, please visit www.novadaq.com.

¹Pittman, Troy A., et al. "Comparison of Different Acellular Dermal Matrix (ADM) in Breast Reconstruction: The 50/50 Study." Plastic and Reconstructive Surgery (2016).

SOURCE LifeNet Health