FOR IMMEDIATE RELEASE
JUPITER, Fla. (May 10, 2013) – Jupiter Medical Center’s Clinical Research Department is extending its relationship with TEI Biosciences (Boston, MA) through an upcoming research collaboration studying the effectiveness of SurgiMend PRS in two populations of women undergoing mastectomy. The new clinical trials will be headed by Jupiter Medical Center surgeons David Lickstein, MD, Plastic Surgery, and John A.P. Rimmer, MD, General and Breast Surgery and Medical Director of the Kristin Hoke Breast Health Program.
The partnership originated as Dr. Lickstein and Dr. Rimmer recently completed a study with TEI Biosciences as principal investigators in a “Acellular Dermal Matrix (ADM) in Tissue Expander or Direct-to-Implant Reconstruction: A Retrospective, Observational Study.” Additionally, TEI Biosciences chose Jupiter Medical Center as a clinical research site due to their level of expertise and commitment to leading-edge research.
The purpose of the retrospective ADM study was to compare the effectiveness of TEI Biosciences’ SurgiMend PRS to other comparable products currently being used in women undergoing breast reconstruction with expanders and/or implant after mastectomy. These ADM products are used as a soft tissue repair matrix to support the patient’s own breast tissue, sustaining the healing skin around the breast expander or implant, and promoting the patient’s own cells to rebuild healthy tissue.
As part of the study, women who underwent the surgeries due to breast cancer or as a preventative measure had a follow-up visit with Dr. Lickstein or Dr. Rimmer within six weeks post-operatively. They were assessed for side effects such as hematoma (a collection of blood within the tissue), seroma (a pocket of clear fluid that develops in the surgical site), necrosis (the death of tissue cells), infection, and/or the necessity to remove the implant or expander.
The results of the assessment of the women who had SurgiMend PRS were compared with women who had Strattice, Alloderm and other ADMs used in reconstructions. These products are FDA-approved and assist surgeons in many settings such as emergency reconstruction, hernia repair and wound healing. SurgiMend PRS and other ADMs have shown positive results when used during the breast reconstruction process. However, they must undergo clinical trials in order to make specific claims about patient benefits.
As a result of the retrospective ADM study, and upon FDA-approval of the new clinical trial protocols, the research collaboration studying the effectiveness of SurgiMend PRS in two populations of women undergoing mastectomy will begin. The first clinical trial will compare two-stage reconstruction following mastectomy with and without the use of SurgiMend PRS in patients with pre-mastectomy radiation therapy, studying the product’s potential to reduce capsular contracture (tightening of tissue around the breast implant). The second clinical trial will determine the clinical outcome and effectiveness of SurgiMend PRS when used during single-state breast reconstruction following mastectomy compared to immediate, two-stage breast reconstruction following mastectomy without ADM, studying the potential reduction in number of operations to achieve a desirable appearance.
Jupiter Medical Center’s Clinical Research Department is excited to begin work on the new clinical trials, in partnership with TEI Biosciences. For more information on this future collaboration, please contact Jupiter Medical Center’s Clinical Research Department at (561) 263-5791, Dr. David Lickstein at (561) 881-8800 or Dr. John Rimmer at (561) 748-1242.
About Jupiter Medical Center
A not-for-profit 283-bed regional medical center consisting of 163 private acute care hospital beds and 120 long-term care, sub-acute rehabilitation and Hospice beds, Jupiter Medical Center provides a broad range of services with specialty concentrations in oncology, imaging, orthopedics & spine, digestive health, emergency services, lung & thoracic, women’s health, weight management and men’s health. Founded in 1979, the Medical Center has approximately 1,500 team members, 520 physicians and 700 volunteers. Jupiter Medical Center is the recipient of the HealthGrades ‘America’s 50 Best’ Award™ for three years in a row (2011-2013) and the Distinguished Hospital Award - Clinical Excellence™ for nine years in a row (2005-2013). For more information on Jupiter Medical Center, please call (561) 263-2234 or visit www.jupitermed.com.
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