Prospective, multicenter study of P4HB (Phasix™) mesh for hernia repair in cohort at risk for complications: 3-Year follow-up
| Autor: | John Scott Roth, David B. Earle, Corey R. Deeken, John Romanelli, Guy R. Voeller, Raymond M. Dunn, Jasenka Verbarg, Richard A. Pierce, Don J. Selzer, Benjamin K. Poulose, Jacob A. Greenberg, Robert G. Martindale, Jennifer Salluzzo, Matthew I. Goldblatt, James G. Bittner, Bryan J. Sandler, Gary J. Anthone, Gregory J. Mancini, William W. Hope, John G. Linn, Eduardo Parra-Davila |
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| Rok vydání: | 2021 |
| Předmět: |
Poly-4-hydroxybutyrate
medicine.medical_specialty medicine.medical_treatment 030230 surgery Coronary artery disease 03 medical and health sciences 0302 clinical medicine Quality of life Recurrence medicine Hernia Original Research Mesh COPD business.industry General Medicine medicine.disease Hernia repair Myofascial release Surgery Seroma 030220 oncology & carcinogenesis Cohort Infection business |
| Zdroj: | Annals of Medicine and Surgery |
| ISSN: | 2049-0801 |
| Popis: | Background This study represents a prospective, multicenter, open-label study to assess the safety, performance, and outcomes of poly-4-hydroxybutyrate (P4HB, Phasix™) mesh for primary ventral, primary incisional, or multiply-recurrent hernia in subjects at risk for complications. This study reports 3-year clinical outcomes. Materials and methods P4HB mesh was implanted in 121 patients via retrorectus or onlay technique. Physical exam and/or quality of life surveys were completed at 1, 3, 6,12, 18, 24, and 36 months, with 5-year (60-month) follow-up ongoing. Results A total of n = 121 patients were implanted with P4HB mesh (n = 75 (62%) female) with a mean age of 54.7 ± 12.0 years and mean BMI of 32.2 ± 4.5 kg/m2 (±standard deviation). Comorbidities included: obesity (78.5%), active smokers (23.1%), COPD (28.1%), diabetes mellitus (33.1%), immunosuppression (8.3%), coronary artery disease (21.5%), chronic corticosteroid use (5.0%), hypo-albuminemia (2.5%), advanced age (5.0%), and renal insufficiency (0.8%). Hernias were repaired via retrorectus (n = 45, 37.2% with myofascial release (MR) or n = 43, 35.5% without MR), onlay (n = 8, 6.6% with MR or n = 24, 19.8% without MR), or not reported (n = 1, 0.8%). 82 patients (67.8%) completed 36-month follow-up. 17 patients (17.9% ± 0.4%) experienced hernia recurrence at 3 years, with n = 9 in the retrorectus group and n = 8 in the onlay group. SSI (n = 11) occurred in 9.3% ± 0.03% of patients. Conclusions Long-term outcomes following ventral hernia repair with P4HB mesh demonstrate low recurrence rates at 3-year (36-month) postoperative time frame with no patients developing late mesh complications or requiring mesh removal. 5-year (60-month) follow-up is ongoing. Highlights • Prospective, multicenter, open-label study of safety, performance, and outcomes. • Poly-4-hydroxybutyrate mesh implanted in n = 121 patients via retrorectus or onlay. • 82 patients (67.8%) completed 36-month follow-up. • Hernia recurrence (n = 17, 17.9% ± 0.4%) and SSI (n = 11, 9.3% ± 0.03%) at 3 years. • No patients developed late mesh complications or required mesh removal. |
| Databáze: | OpenAIRE |
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