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
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.
Roth JS, Anthone GJ, Selzer DJ, Poulose BK, Pierce RA, Bittner JG, Hope WW, Dunn RM, Martindale RG, Goldblatt MI, Earle DB, Romanelli JR, Mancini GJ, Greenberg JA, Linn JG, Parra-Davila E, Sandler BJ, Deeken CR, Badhwar A, Salluzzo JL, Voeller GR. 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. J Am Coll Surg. 2022 Aug 17. doi: 10.1097/XCS.0000000000000363. Epub ahead of print.