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

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Introduction: 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 1 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 (SSI). Secondary outcomes included pain, device-related adverse events, quality of life, re-operation, procedure time, and length of stay. Evaluations were scheduled at 1, 3, 6 ,12, 18, 24, 30, 36, and 60 month. A time-to-event analysis (Kaplan-Meier) was performed for primary outcomes; secondary outcomes were reported as descriptive statistics.

Results: 121 patients (46M, 75F) 54.7+/-12.0 years old with a BMI of 32.2 +/-4.5 kg/m2 underwent VIHR with P4HB Mesh (mean ± SD). Fifty-four patients (44.6%) completed 60-month follow-up. Primary outcomes (Kaplan-Meier estimates at 60-months) included: recurrence (22.0 ± 4.5%; 95% Confidence Interval (CI): 11.7, 29.4%) and SSI (10.1 ± 2.8%; 95% CI: 3.3, 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), re-operation (18/121, 14.9%), Visual Analog 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).

Conclusion: Five-year outcomes following 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 utilizing P4HB mesh.