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

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...

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Autores principales:	George DeNoto, Eugene P. Ceppa, Salvatore J. Pacella, Michael Sawyer, Geoffrey Slayden, Mark Takata, Gary Tuma, Jonathan Yunis
Formato:	article
Lenguaje:	EN
Publicado:	MDPI AG 2021
Materias:	ventral hernia repair reinforced tissue matrix decellularized extracellular matrix recurrence Medicine R
Acceso en línea:	https://doaj.org/article/5cc024be386c4d3693852d2edfa26a33
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spelling	oai:doaj.org-article:5cc024be386c4d3693852d2edfa26a332021-11-11T17:37:33ZA Prospective, Single Arm, Multi-Center Study Evaluating the Clinical Outcomes of Ventral Hernias Treated with OviTex<sup>®</sup> 1S Permanent Reinforced Tissue Matrix: The BRAVO Study 12-Month Analysis10.3390/jcm102149982077-0383https://doaj.org/article/5cc024be386c4d3693852d2edfa26a332021-10-01T00:00:00Zhttps://www.mdpi.com/2077-0383/10/21/4998https://doaj.org/toc/2077-0383Background: 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<sup>®</sup> 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/m<sup>2</sup>. 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.George DeNotoEugene P. CeppaSalvatore J. PacellaMichael SawyerGeoffrey SlaydenMark TakataGary TumaJonathan YunisMDPI AGarticleventral hernia repairreinforced tissue matrixdecellularized extracellular matrixrecurrenceMedicineRENJournal of Clinical Medicine, Vol 10, Iss 4998, p 4998 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	ventral hernia repair reinforced tissue matrix decellularized extracellular matrix recurrence Medicine R
spellingShingle	ventral hernia repair reinforced tissue matrix decellularized extracellular matrix recurrence Medicine R George DeNoto Eugene P. Ceppa Salvatore J. Pacella Michael Sawyer Geoffrey Slayden Mark Takata Gary Tuma Jonathan Yunis A Prospective, Single Arm, Multi-Center Study Evaluating the Clinical Outcomes of Ventral Hernias Treated with OviTex<sup>®</sup> 1S Permanent Reinforced Tissue Matrix: The BRAVO Study 12-Month Analysis
description	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<sup>®</sup> 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/m<sup>2</sup>. 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.
format	article
author	George DeNoto Eugene P. Ceppa Salvatore J. Pacella Michael Sawyer Geoffrey Slayden Mark Takata Gary Tuma Jonathan Yunis
author_facet	George DeNoto Eugene P. Ceppa Salvatore J. Pacella Michael Sawyer Geoffrey Slayden Mark Takata Gary Tuma Jonathan Yunis
author_sort	George DeNoto
title	A Prospective, Single Arm, Multi-Center Study Evaluating the Clinical Outcomes of Ventral Hernias Treated with OviTex<sup>®</sup> 1S Permanent Reinforced Tissue Matrix: The BRAVO Study 12-Month Analysis
title_short	A Prospective, Single Arm, Multi-Center Study Evaluating the Clinical Outcomes of Ventral Hernias Treated with OviTex<sup>®</sup> 1S Permanent Reinforced Tissue Matrix: The BRAVO Study 12-Month Analysis
title_full	A Prospective, Single Arm, Multi-Center Study Evaluating the Clinical Outcomes of Ventral Hernias Treated with OviTex<sup>®</sup> 1S Permanent Reinforced Tissue Matrix: The BRAVO Study 12-Month Analysis
title_fullStr	A Prospective, Single Arm, Multi-Center Study Evaluating the Clinical Outcomes of Ventral Hernias Treated with OviTex<sup>®</sup> 1S Permanent Reinforced Tissue Matrix: The BRAVO Study 12-Month Analysis
title_full_unstemmed	A Prospective, Single Arm, Multi-Center Study Evaluating the Clinical Outcomes of Ventral Hernias Treated with OviTex<sup>®</sup> 1S Permanent Reinforced Tissue Matrix: The BRAVO Study 12-Month Analysis
title_sort	prospective, single arm, multi-center study evaluating the clinical outcomes of ventral hernias treated with ovitex<sup>®</sup> 1s permanent reinforced tissue matrix: the bravo study 12-month analysis
publisher	MDPI AG
publishDate	2021
url	https://doaj.org/article/5cc024be386c4d3693852d2edfa26a33
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A Prospective, Single Arm, Multi-Center Study Evaluating the Clinical Outcomes of Ventral Hernias Treated with OviTex<sup>®</sup> 1S Permanent Reinforced Tissue Matrix: The BRAVO Study 12-Month Analysis

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