Browsing by Author "Yunis, Jonathan"

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    24-Month results of the BRAVO study: A prospective, multi-center study evaluating the clinical outcomes of a ventral hernia cohort treated with OviTex® 1S permanent reinforced tissue matrix
    (Elsevier, 2022-09-27) DeNoto, George, III.; Ceppa, Eugene P.; Pacella, Salvatore J.; Sawyer, Michael; Slayden, Geoffrey; Takata, Mark; Tuma, Gary; Yunis, Jonathan; Surgery, School of Medicine
    Background: This study evaluated the performance of OviTex® 1S (TELA Bio Inc., Malvern, PA, USA) over 24 months when used for ventral hernia repair. Methods: This was a prospective, single-arm, multi-center clinical trial (ClinicalTrials.gov/NCT03074474). A ninety-two patient cohort with ventral hernias were enrolled. The surgical approach (open, laparoscopic, or robotic) and plane of placement (retrorectus, intraperitoneal, or pre-peritoneal) were at the discretion of the surgeon. Patients were characterized as high risk for a surgical site occurrence (SSO) based on the following comorbidities: BMI between 30 and 40, active smoker, chronic obstructive pulmonary disease (COPD), diabetes mellitus, coronary artery disease, advanced age ( ≥ 75 years). Subjects underwent physical examinations to evaluate safety events and completed quality of life surveys at 1 months, 3 months, 12 months, and 24 months post-surgery. Results: Sixty-five of the 92 enrolled patients (70.7%) completed 24-month follow-up. The Kaplan Meier estimate for risk of recurrence at day 730 (24 months) was 2.6%; among subjects who completed their 24-month visit or had a previous recurrence, the unadjusted rate of recurrence was 4.5% (3/66). SSOs were observed in 38.0% of patients (35/92). The most prevalent SSO was surgical site infection occurring in 20.7% (19/92) of patients, followed by seroma formation, which occurred in 13.0% of patients; however, only 3.3% required intervention. HerQLes and EQ-5D assessments showed improvement from baseline as soon as 3 months post-surgery. Continued improvement was observed through 24 months. Conclusions: Overall the BRAVO study demonstrates that use of the ovine reinforced tissue matrix OviTex 1S is a viable option for use in ventral hernia repair. Additional studies with longer term follow-up data are needed to draw definitive conclusions on the use of OviTex 1S.
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    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
    (MDPI, 2021-10-27) DeNoto, George, III.; Ceppa, Eugene P.; Pacella, Salvatore J.; Sawyer, Michael; Slayden, Geoffrey; Takata, Mark; Turma, Gary; Yunis, Jonathan; Surgery, School of Medicine
    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.