Table 4.
Summary of recently published ventral hernia studies.
| DeNoto, 2022 (BRAVO) | Roth, 2021 (Phasix)[20] | Hope, 2022 (ATLAS)[21] | Harris, 2021 (PRICE)[25] | ||
|---|---|---|---|---|---|
| Total Pts | 92 | 121 | 120 | 82 | 83 |
| Mesh Type | Reinforced tissue matrix | Resorbable Synthetic | Resorbable Synthetic | Biologic | Permanent Synthetic |
| Mesh Composition | Ovine forestomach matrix and polypropylene | Poly-4-hydroxybutyrate (P4HB) | Poly-4hydroxybutyrate (P4HB) with a hydrogel barrier | Porcine dermis | Polypropylene with hydrogel barrier or polypropylene |
| Trade Name | OviTex™ 1S Permanent1 | Phasix™ Mesh2 | Phasix-STTM Mesh2 | Strattice3 | Ventralight ST or Soft Mesh4 |
| Follow-Up | 24 Months | 36 Months | 24 Months | 26 Months | |
| Surgical Approach | Open (65%) Laparoscopic (13%) Robotic (22%) |
Open | Laparoscopic (55.8%) Robotic (44.2%) |
Open | |
| Plane of Placement | Retrorectus (53%) Intraperitoneal (46%) Retrofascial/Pre-Peritoneal (1.1%) Onlay (1.1%) |
Retrorectus (73%) Onlay (26%) |
Intrabdominal | Onlay (17%) Sublay/Retrorectus (38%) Underlay (30%) |
Onlay (28%) Sublay/Retrorectus (30%) Underlay (31%) |
| Primary Closure | 92% | 94% | N/A | 85% | 89% |
| Component Separation | 51% | 43.8% | 1.7% | 35% | 46% |
| BMI (kg/m2) | 31.0 ± 4.51 | 32.2 ± 4.5 | 33.2 ± 4.5 | 36.1 ± 9.6 | 35.0 ± 7.7 |
| CDC Wound Class | I (80%) II (15%) III (4%) |
I (100%) | I (100%) | I (67%) II (23%) III (1%) IV (9%) |
I (70%) II (23%) III (0%) IV (7%) |
| Incidence of SSO/Complications | 38% SSO(including SSI) | 6.6% (Seroma req. int only) 15.7% (Device related AEs) |
0.8%a<45 Days 0.0%a>45 Days (req. intervention0 |
21% SSO (excluding SSI) | 22% SSO (excluding SSI) |
| Incidence of SSI | 20.7% | 9.3 ± 0.03%a | 0% | 39% | 34% |
| Recurrence Rate (Final Follow Up Population) | 4.5% (3/66) | – | – | 40% (25/63) | 22% (14/64) |
| Recurrence Rate(Kaplan Meier estimate) | 2.6%a | 17.9 ± 0.4%a | 31.7% (18.6% defects <7.1 cm2 and 43.3% defects >7.1 cm2)a | – | – |
a
Kaplan Meier estimate 1: TELA Bio, Inc., Malvern, PA; 2: C.R. Bard, Inc., Warwick, RI; 3: LifeCell Corporation, Branchburg, NJ; 4: Becton, Dickinson & Company (BD), Franklin Lakes, NJ.