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/m2underwent 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.
| Original language | English |
|---|---|
| Pages (from-to) | 894-904 |
| Number of pages | 11 |
| Journal | Journal of the American College of Surgeons |
| Volume | 235 |
| Issue number | 6 |
| DOIs | |
| State | Published - Dec 1 2022 |
Bibliographical note
Publisher Copyright:© 2022 Elsevier Inc.. All rights reserved.
Funding
Disclosures outside the scope of this work: Dr Roth’s institute received grant funding from BD during the study period and receives grant funding from Advanced Medical Solutions. Dr Roth is a paid consultant to Johnson & Johnson and BD, holds stock in Miromatrix, and receives speaker fees from Allergan. Dr Selzer’s institute received grant funding from Becton Dickinson. Dr Selzer is a paid consultant to Cook Biotechnology and Becton Dickinson, and was a paid consultant to PolyNovo, Inc. Dr Poulose receives research funding from Advanced Medical Solutions and BD, is a paid consultant to Ethicon, and is the majority owner of EndoEvolve, LLC. Dr Goldblatt is a paid consultant to WL Gore, Medtronic, and Allergan. Dr Goldblatt’s institute receives research funding from WL Gore and Medtronic. Dr Deeken is a paid consultant to Johnson & Johnson, Medtronic, SurgiMatrix, Tissium, Surgical Innovation Associates, Americas Hernia Society Quality Collaborative, Colorado Therapeutics, TelaBio, and Aran Biomedical; is the owner of Covalent Bio, LLC; and holds the following issued patents: 2009293001, 2334257, 2,334,257UK, 602009046407.8, 2,334,257FR, 16/043,849, and 2,737,542. Dr Anthone receives consulting fees and speaker honoraria from Becton Dickinson. Dr Pierce receives research support from Intuitive Surgical Solutions, and his spouse is a salaried employee of CareFusion, which falls under the overall umbrella of the parent company, Becton Dickinson. Dr Bittner receives consulting/speaker fees and travel support from Cook Biotech, Inc, Intuitive Surgical, Inc, Becton Dickinson, and CMR Surgical Ltd. Dr Linn receives consultant/speaker fees from WL Gore. Dr Hope receives consultant fees, honoraria, and research support from Intuitive, WL Gore, and Medtronic, and honoraria payments from Becton Dickinson. Dr Martindale is a paid consultant to Allergan, CR Bard, Inc/Davol/Becton Dickinson, and Nestle. Dr Badhwar is an employee of Becton Dickinson. Dr Parra-Davila receives consultant/speaker fees from Bard, Inc/Davol/Becton Dickinson, Intuitive, Johnson & Johnson, and Medtronic; research funds from CR Bard, Inc/Davol/Becton Dickinson; and proctoring fees from Intuitive. Dr Earle is a paid consultant to Becton Dickinson and Medtronic and is a paid advisory board member at Via Surgical. Dr Mancini is a paid consultant to Stryker Endoscopy and receives speaker fees from Gore Medical and Medtronic. Dr Greenberg receives grant funding from Becton Dickinson and Medtronic, and course registration, travel, and lodging from Intuitive. Dr Romamelli is a paid consultant to New View Surgical. Dr Salluzzo’s institute receives grant funding from Davol, Inc. Dr Dunn receives grant funding from Becton Dickinson. Other authors have nothing to disclose. Disclosure Information: This study was sponsored by Becton Dickinson (BD). Authors were reimbursed for expenses related to the conduct of the study.
| Funders | Funder number |
|---|---|
| Advanced Medical Solutions Group Plc | |
| Becton Dickinson | |
| Becton Dickinson and Medtronic | |
| Davol Inc Speciality Access Products |
ASJC Scopus subject areas
- General Medicine