A Prospective, Single Arm, Multi-Center Study Evaluating the Clinical Outcomes of Ventral Hernias Treated with OviTex® 1S Permanent Reinforced Tissue Matrix: The BRAVO Study 12-Month Analysis

George DeNoto 3rd; Eugene P Ceppa; Salvatore J Pacella; Michael Sawyer; Geoffrey Slayden; Mark Takata; Gary Tuma; Jonathan Yunis

doi:10.3390/jcm10214998

A Prospective, Single Arm, Multi-Center Study Evaluating the Clinical Outcomes of Ventral Hernias Treated with OviTex^® 1S Permanent Reinforced Tissue Matrix: The BRAVO Study 12-Month Analysis

J Clin Med. 2021 Oct 27;10(21):4998. doi: 10.3390/jcm10214998.

Authors

George DeNoto 3rd¹, Eugene P Ceppa², Salvatore J Pacella³, Michael Sawyer⁴, Geoffrey Slayden⁵, Mark Takata⁶, Gary Tuma⁷, Jonathan Yunis⁸

Affiliations

¹ Department of General Surgery, St. Francis Hospital, Roslyn, NY 11576, USA.
² Department of Surgery, Indiana University School of Medicine, Indianapolis, IN 46202, USA.
³ Scripps Clinic and Scripps M.D. Anderson Cancer Center, Division of Plastic and Reconstructive Surgery, San Diego, CA 92130, USA.
⁴ Department of Surgery, Comanche County Memorial Hospital, Lawton, OK 73505, USA.
⁵ St. Luke's Surgical Specialists, St. Luke's Health System, Overland Park, KS 66213, USA.
⁶ Scripps Clinic Medical Group, Department of Surgery, La Jolla, CA 92037, USA.
⁷ Capital Health Medical Group, Department of Plastic Surgery, Pennington, NJ 08534, USA.
⁸ Hernia Specialist, Center for Hernia Repair, Sarasota, FL 34239, USA.

Abstract

Background: Conflicting results from previous studies have led to dissent over whether surgical mesh is safe and effective in ventral hernia repair. A newer class of mesh known as a reinforced tissue matrix, combining a biologic scaffold and minimal polymer reinforcement, offers promise in reducing inflammatory response and increasing abdominal wall support. This study sought to assess the clinical utility of a reinforced tissue matrix (OviTex) in ventral hernia repair 12 months after implantation.

Methods: This is a prospective, single-arm, multi-center study to evaluate the clinical performance of OviTex^® 1S Permanent (OviTex) in the repair of primary or recurrent ventral hernias (VH) in consecutive patients (ClinicalTrials.gov/NCT03074474). The rate of surgical site occurrences (SSOs) was evaluated 90 days post-surgery as the primary endpoint. Hernia recurrence and the incidence of postoperative events were evaluated between three and 12 months as secondary endpoints. The incidence of other complications and patient-reported outcomes were also recorded.

Results: Ninety-two (92) patients were enrolled in the study, of whom seventy-six (76) reached the 12-month follow-up. All patients were at least 18 years of age with a BMI of <40 kg/m². Hernia defects were <20 × 20 cm, classified as class I-III according to the CDC wound classification system. Of the 76 patients who reached 12-month follow-up, twenty-six (34%) had previous VH repairs and thirteen (17%) had previous surgical infection. Sixty (79%) had factors known to increase the risk of recurrence. Twenty patients (26%) experienced SSOs, with ten (13%) requiring procedural intervention. Two of the 75 patients (2.7%) experienced a recurrence.

Conclusions: The low rate of hernia recurrence and SSOs requiring intervention illustrates the potential that reinforced tissue matrices, and OviTex 1S, in particular, have to improve outcomes in VH repairs. Follow-up to 24 months is ongoing.

Keywords: decellularized extracellular matrix; recurrence; reinforced tissue matrix; ventral hernia repair.

Associated data

ClinicalTrials.gov/NCT03074474

Grants and funding

N/A/TELA Bio Inc