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
dc.contributor.author | DeNoto, George, III. | |
dc.contributor.author | Ceppa, Eugene P. | |
dc.contributor.author | Pacella, Salvatore J. | |
dc.contributor.author | Sawyer, Michael | |
dc.contributor.author | Slayden, Geoffrey | |
dc.contributor.author | Takata, Mark | |
dc.contributor.author | Turma, Gary | |
dc.contributor.author | Yunis, Jonathan | |
dc.contributor.department | Surgery, School of Medicine | |
dc.date.accessioned | 2023-03-27T10:51:59Z | |
dc.date.available | 2023-03-27T10:51:59Z | |
dc.date.issued | 2021-10-27 | |
dc.description.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. | en_US |
dc.eprint.version | Final published version | en_US |
dc.identifier.citation | DeNoto G 3rd, Ceppa EP, Pacella SJ, et al. 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;10(21):4998. Published 2021 Oct 27. doi:10.3390/jcm10214998 | en_US |
dc.identifier.uri | https://hdl.handle.net/1805/32069 | |
dc.language.iso | en_US | en_US |
dc.publisher | MDPI | en_US |
dc.relation.isversionof | 10.3390/jcm10214998 | en_US |
dc.relation.journal | Journal of Clinical Medicine | en_US |
dc.rights | Attribution 4.0 United States | |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ | * |
dc.source | PMC | en_US |
dc.subject | Ventral hernia repair | en_US |
dc.subject | Reinforced tissue matrix | en_US |
dc.subject | Decellularized extracellular matrix | en_US |
dc.subject | Recurrence | en_US |
dc.title | 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 | en_US |
dc.type | Article | en_US |