Outcomes with porcine acellular dermal matrix versus synthetic mesh and suture in complicated open ventral hernia repair

Background: Mesh reinforcement as part of open ventral hernia repair (OVHR) has become the standard of care. However, there is no consensus on the ideal type of mesh to use. In many clinical situations, surgeons are reluctant to use synthetic mesh. Options in these complicated OVHRs include suture repair or the use of biologic mesh such as porcine acellular dermal matrix (PADM). There has been a paucity of controlled studies reporting long-term outcomes with biologic meshes. We hypothesized that compared with synthetic mesh in OVHR, PADM is associated with fewer surgical site infections (SSI) but more seromas and recurrences. Additionally, compared with suture repair, we hypothesized that PADM is associated with fewer recurrences but more SSIs and seromas.

Methods: A retrospective study was performed of all complicated OVHRs performed at a single institution from 2000-2011. All data were captured from the electronic medical records of the service network. Data were compared in two ways. First, patients who had OVHR with PADM were case-matched with patients having synthetic mesh repairs on the basis of incision class, Ventral Hernia Working Group (VHWG) grade, hernia size, American Society of Anesthesiologists (ASA) class, and emergency status. The PADM cases were also matched with suture repairs on the basis of incision class, hernia grade, duration of the operation, ASA class, and emergency status. Second, we developed a propensity score-adjusted multi-variable logistic regression model utilizing internal resampling to identify predictors of primary outcomes of the overall cohort. The U.S. Centers for Disease Control and Prevention (CDC) definition of SSI was utilized; seromas and recurrences were defined and tracked similarly for all patients. Data were analyzed using the McNemar, X², paired two-tailed Student t, or Mann-Whitney U test as appropriate.

Conclusions: The PADM repair of complicated OVHR resulted in fewer recurrences, more seromas, and no difference in SSI compared with suture repair. Although no reduction in SSI was identified with the use of PADM rather than synthetic mesh or suture for OVHR, the meaning of this finding is unclear, as this case-controlled study was underpowered and limited by selection bias. According to our data, 280 patients would have been needed to identify a clinically significant difference in the primary outcome of SSI as well as secondary outcomes of mesh explantation and recurrence (α=0.05; β=0.20). A randomized trial is warranted to compare PADM with synthetic mesh in complicated OVHR.

Results: A total of 449 complicated OVHR cases were reviewed for a median follow up of 61mos (range 1-143mos): 94 patients had PADM repairs, whereas 154 patients underwent synthetic mesh repairs, and 201 had suture repairs. The 40 PADM repairs were matched to synthetic repairs and 59 were matched to suture repairs. The PADM repairs that could not be well matched (n=54 unmatched for synthetic repairs, 35 unmatched for suture repairs) were characterized generally by larger hernias, VHWG grades of 3 or 4, and incision class 3 or 4 with longer operative durations and more ASA class 4 cases. The patients were well matched. Comparing PADM with synthetic mesh, there was no difference in SSI (20% vs. 35%; p=0.29), seromas (32.5% vs. 15%; p=0.17), mesh explantations (5% vs. 15%, p=0.28), readmissions within 90 d (37.5% vs. 45%; p=1.00), or recurrence (8.5% vs. 22.5%; p=0.15). Compared with suture repair, patients with PADM had fewer recurrences (11.9% vs. 33.9%; p<0.01) and more seromas (32.2% vs. 10.2%; p=0.02), but a similar number of SSIs (23.7% vs. 39.0%; p=0.19) and 90-d readmissions (35.6% vs. 39.0%; p=0.88). Propensity score-adjusted multi-variable logistic regression of the entire cohort corroborated the results of the case-matched patients.