02 Apr OviTex Reinforced BioScaffolds Combine Synthetic and Biologic Materials For Soft Tissue Repair
MedicalResearch.com Interview with:
Michael Sawyer, MD, FACS
Comanche County Memorial Hospital
MedicalResearch.com: What is the background for this study?
Response: Repair of complex incisional hernias is a challenging surgical task. Abdominal wall surgeons are utilizing advanced abdominal wall reconstruction (AWR) techniques including myofascial advancement flap creation with reinforcement by biologic or synthetic prostheses with greater frequency.
Numerous synthetic or biologic surgical mesh products are currently available to reinforce these soft tissue repairs. Each type of biologic or synthetic material has its own advantages and limitations.
OviTex Reinforced BioScaffolds (RBSs) are unique in that they interweave polymer in a custom “lock-stitch” pattern through layers of biologic tissue in an embroidered construction, aiming to incorporate the salutary properties of both biologic and synthetic repair materials. The biologic material, derived from ovine rumen, has been optimized to minimize foreign body response and enables functional tissue remodeling. The polymer provides additional strength, along with improved handling and load‑sharing capability.
MedicalResearch.com: What are the main findings?
Response: Our retrospective study examined 14 patients with complex incisional hernias undergoing abdominal wall repair with OviTex RBSs used for reinforcement between June 2016 and November 2017. Results from the study show a low recurrence rate (7.1%) and low complication rate (14.3%) at average follow up of about one year. Several of the patients had multiple recurrences of their hernia defects. The mean number of comorbidities in the group was 3.3. Some also had a history or prior wound infection
MedicalResearch.com: What should readers take away from your report?
Response: This is the first reported series of the use of OviTex RBSs in abdominal wall repairs. This new product possesses properties of both synthetic and biologic materials and represents a new paradigm in soft tissue repair reinforcement that may improve patient outcomes and warrants longer-term study. The American Hernia Society Quality Collaborative has recognized the unique nature of the OviTex product portfolio, and therefore has created a category for these products that distinguishes them from all other repair and reinforcement materials in current clinical use.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: OviTex RBSs have now been used in over 1,700 implantations in a wide range of hernia procedures using a variety of surgical techniques. The company that commercializes the product, TELA Bio, has initiated a post-market clinical study, BioScaffold Reconstruction of Abdominal wall and Ventral hernia defects with Open or laparoscopic repair (BRAVO) to further evaluate the efficacy and safety of OviTex RBSs.
Additionally, longer term follow up on this patient population, and data from the clinical experience of other surgeons will be extremely valuable
MedicalResearch.com: Is there anything else you would like to add?
Response: The results from our study were presented at the Americas Hernia Society (AHS) International Hernia Congress 2018 held March 12-15 at the Fontainebleau Miami Beach in Florida. My disclosure is that I am a paid consultant for TELA Bio, Inc.
Data presented at Americas Hernia Society International Hernia Congress 2018 show low recurrence and complication rates.
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