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.
Highlights
Ventral hernias occur when a defect in the abdominal wall allows the protrusion of organs and tissues outside of the abdomen [1]
This prospective, single-arm, multi-center study evaluates the clinical performance of OviTex® 1S Permanent (OviTex) 1S Permanent for primary or recurrent ventral hernia repair (ClinicalTrials.gov/NCT03074474)
The loss of eight patients occurred as four patients died from unrelated causes, one withdrew consent, and three were excluded as screening failures prior to implantation
Summary
Ventral hernias occur when a defect in the abdominal wall allows the protrusion of organs and tissues outside of the abdomen [1]. Ventral hernias impair quality of life as they are painful and can prevent the patient from completing daily activities. Conflicting results from previous studies have led to dissent over whether surgical mesh is safe and effective in ventral hernia repair. This study sought to assess the clinical utility of a reinforced tissue matrix (OviTex) in ventral hernia repair. 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). Hernia recurrence and the incidence of postoperative events were evaluated between three and 12 months as secondary endpoints. Results: Ninety-two (92) patients were enrolled in the study, of whom seventy-six (76)
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