Prospective, multicenter study of P4HB (Phasix™) mesh for hernia repair in cohort at risk for complications: 3-Year follow-up
dc.contributor.author | Roth, John Scott | |
dc.contributor.author | Anthone, Gary J. | |
dc.contributor.author | Selzer, Don J. | |
dc.contributor.author | Poulose, Benjamin K. | |
dc.contributor.author | Pierce, Richard A. | |
dc.contributor.author | Bittner, James G. | |
dc.contributor.author | Hope, William W. | |
dc.contributor.author | Dunn, Raymond M. | |
dc.contributor.author | Martindale, Robert G. | |
dc.contributor.author | Goldblatt, Matthew I. | |
dc.contributor.author | Earle, David B. | |
dc.contributor.author | Romanelli, John R. | |
dc.contributor.author | Mancini, Gregory J. | |
dc.contributor.author | Greenberg, Jacob A. | |
dc.contributor.author | Linn, John G. | |
dc.contributor.author | Parra-Davila, Eduardo | |
dc.contributor.author | Sandler, Bryan J. | |
dc.contributor.author | Deeken, Corey R. | |
dc.contributor.author | Verbarg, Jasenka | |
dc.contributor.author | Salluzzo, Jennifer L. | |
dc.contributor.author | Voeller, Guy R. | |
dc.contributor.department | Surgery, School of Medicine | en_US |
dc.date.accessioned | 2022-04-22T15:49:54Z | |
dc.date.available | 2022-04-22T15:49:54Z | |
dc.date.issued | 2021-01 | |
dc.description.abstract | 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. | en_US |
dc.eprint.version | Final published version | en_US |
dc.identifier.citation | Roth, J. S., Anthone, G. J., Selzer, D. J., Poulose, B. K., Pierce, R. A., Bittner, J. G., ... & Voeller, G. R. (2021). Prospective, multicenter study of P4HB (Phasix™) mesh for hernia repair in cohort at risk for complications: 3-Year follow-up. Annals of Medicine and Surgery, 61, 1-7. https://doi.org/10.1016/j.amsu.2020.12.002 | en_US |
dc.identifier.uri | https://hdl.handle.net/1805/28709 | |
dc.language.iso | en_US | en_US |
dc.publisher | Elsevier | en_US |
dc.relation.isversionof | 10.1016/j.amsu.2020.12.002 | en_US |
dc.relation.journal | Annals of Medicine & Surgery | en_US |
dc.rights | Attribution 4.0 International | |
dc.rights.uri | https://creativecommons.org/licenses/by/4.0 | |
dc.source | PMC | en_US |
dc.subject | Hernia repair | en_US |
dc.subject | Recurrence | en_US |
dc.subject | Infection | en_US |
dc.subject | Poly-4-hydroxybutyrate | en_US |
dc.subject | Mesh | en_US |
dc.subject | Seroma | en_US |
dc.title | Prospective, multicenter study of P4HB (Phasix™) mesh for hernia repair in cohort at risk for complications: 3-Year follow-up | en_US |
dc.type | Article | en_US |