Long-Term, Prospective, Multicenter Study of Poly-4-Hydroxybutyrate Mesh (Phasix Mesh) for Hernia Repair in Cohort at Risk for Complication: 60-Month Follow-Up

John Scott Roth, Gary J Anthone, Don J Selzer, Benjamin K Poulose, Richard A Pierce, James G Bittner, William W Hope, Raymond M Dunn, Robert G Martindale, Matthew I Goldblatt, David B Earle, John R Romanelli, Gregory J Mancini, Jacob A Greenberg, John G Linn, Eduardo Parra-Davila, Bryan J Sandler, Corey R Deeken, Amit Badhwar, Jennifer L Salluzzo, Guy R Voeller, John Scott Roth, Gary J Anthone, Don J Selzer, Benjamin K Poulose, Richard A Pierce, James G Bittner, William W Hope, Raymond M Dunn, Robert G Martindale, Matthew I Goldblatt, David B Earle, John R Romanelli, Gregory J Mancini, Jacob A Greenberg, John G Linn, Eduardo Parra-Davila, Bryan J Sandler, Corey R Deeken, Amit Badhwar, Jennifer L Salluzzo, Guy R Voeller

Abstract

Background: Long-term resorbable mesh represents a promising technology for ventral and incisional hernia repair (VIHR). This study evaluates poly-4-hydroxybutyrate mesh (P4HB; Phasix Mesh) among comorbid patients with CDC class I wounds.

Study design: This prospective, multi-institutional study evaluated P4HB VIHR in comorbid patients with CDC class I wounds. Primary outcomes included hernia recurrence and surgical site infection. Secondary outcomes included pain, device-related adverse events, quality of life, reoperation, procedure time, and length of stay. Evaluations were scheduled at 1, 3, 6, 12, 18, 24, 30, 36, and 60 months. A time-to-event analysis (Kaplan-Meier) was performed for primary outcomes; secondary outcomes were reported as descriptive statistics.

Results: A total of 121 patients (46 male, 75 female) 54.7 ± 12.0 years old with a BMI of 32.2 ± 4.5 kg/m 2 underwent VIHR with P4HB Mesh (mean ± SD). Fifty-four patients (44.6%) completed the 60-month follow-up. Primary outcomes (Kaplan-Meier estimates at 60 months) included recurrence (22.0 ± 4.5%; 95% CI 11.7% to 29.4%) and surgical site infection (10.1 ± 2.8%; 95% CI 3.3 to 14.0). Secondary outcomes included seroma requiring intervention (n = 9), procedure time (167.9 ± 82.5 minutes), length of stay (5.3 ± 5.3 days), reoperation (18 of 121, 14.9%), visual analogue scale-pain (change from baseline -3.16 ± 3.35 cm at 60 months; n = 52), and Carolinas Comfort Total Score (change from baseline -24.3 ± 21.4 at 60 months; n = 52).

Conclusions: Five-year outcomes after VIHR with P4HB mesh were associated with infrequent complications and durable hernia repair outcomes. This study provides a framework for anticipated long-term hernia repair outcomes when using P4HB mesh.

Trial registration: ClinicalTrials.gov NCT01961687.

Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American College of Surgeons.

Figures

Graphical abstract
Graphical abstract
Figure 1.
Figure 1.
Flow of patients throughout the study period. P4HB, poly-4-hydroxybutyrate.
Figure 2.
Figure 2.
Primary and secondary study endpoints: (A and B) Kaplan-Meier curves for hernia recurrence and surgical site infection (SSI) in all patients treated with poly-4-hydroxybutyrate mesh (dotted lines = 95% CI; there were no additional SSI after 37 days). (C) Visual Analogue Scale for Pain (mean). (D) Carolinas Comfort Scale–Total Score (mean). (E) SF-12 Physical Component Score (mean). (F) SF-12 Mental Component Score (mean). *p

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Source: PubMed

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