ArticleAnnals of medicine and surgery (2012)2022
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.
Article in Annals of medicine and surgery (2012), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03074474 (A Prospective, Single Arm, Multi-center Study Evaluating the Short-term Clinical Outcomes of Ventral Hernias Treated With OviTex Reinforced Bioscaffold.), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Prospective, Single Arm, Multi-center Study Evaluating the Short-term Clinical Outcomes of Ventral Hernias Treated With OviTex Reinforced Bioscaffold.
Who cites it
11 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.
- Efficacy and safety of ovine reinforced tissue matrix for ventral hernia repair: a systematic review and meta-analysis.Hernia : the journal of hernias and abdominal wall surgery · 2026Pooled it
- Robotic parastomal hernia repair with reinforced tissue matrix; lessons learned from our 74-patient cohort.Journal of abdominal wall surgery : JAWS · 2026Article
- Selective use of reinforced tissue matrix in complex abdominal wall reconstruction: a multicenter consensus analysis.Journal of abdominal wall surgery : JAWS · 2026Article
- Article
- Clinical outcome of OviTex reinforced tissue matrix in hernia repair: A systematic review and meta-analysis.Qatar medical journal · 2025Article
- Robotic Vaginal Hernia Repair for Recurrent Vaginal Prolapse Status Post-Radical Cystectomy with an Indiana Pouch.International urogynecology journal · 2024Article
- Reinforced tissue matrix to strengthen the abdominal wall following reversal of temporary ostomies or to treat incisional hernias.World journal of gastrointestinal surgery · 2024Article
- Definitive Closure Using an Ovine Reinforced Tissue Matrix in Contaminated Penetrating Abdominal Trauma.The American journal of case reports · 2024Article
- Comment to: Comparison of mechanical properties and host tissue response to OviTex™ and Strattice™ surgical meshes.Hernia : the journal of hernias and abdominal wall surgery · 2024Article
- A Comparison of Ovine-Reinforced Hybrid Mesh (OviTex PRS) With Porcine Acellular Dermal Matrix (STRATTICE) in the Treatment of Advanced Breast Implant Capsular Contracture.Aesthetic surgery journal. Open forum · 2024Article
- A Review of Abdominal Meshes for Hernia Repair-Current Status and Emerging Solutions.Materials (Basel, Switzerland) · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 8 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.