Comparative Outcomes of Two Non-Crosslinked Porcine Acellular Dermal Matrices in Complex Abdominal Wall Reconstruction: A Randomized Controlled Trial and an Observational Cohort Study.

BACKGROUND

Biologic mesh has historically been used for ventral hernia repairs (VHR) in contaminated fields in an off-label fashion due to early evidence suggesting that they may be able to withstand these conditions more favorably than synthetic mesh. This study aims to compare outcomes of two non-crosslinked porcine acellular dermal matrices-XenMatrix (Bard, Covington, GA) and Strattice (LifeCell Corporation, Bridgewater, NJ) used in VHR.

METHODS

Patients who were undergoing elective open VHR were randomized to receive either XenMatrix or Strattice mesh (randomized controlled trial-RCT cohort). An additional cohort of patients were recruited in a retrospective observational study cohort. Surgical site occurrence (SSO) was the primary outcome evaluated with hernia recurrence being a secondary outcome measure. Simple and multivariate logistic regression analyses were conducted separately for the RCT and observational cohorts.

RESULTS

Forty-six patients were randomized into the RCT cohort, and an additional 20 patients were recruited into the observational study cohort. There was no difference in baseline characteristics between the two mesh groups in both the RCT and observational cohorts. In the RCT cohort, the 6-week SSO rate was significantly higher for XenMatrix (36.7%) than Strattice (6.3%) (p = 0.03), and on multivariate analysis, XenMatrix was associated with higher 6-week SSO risk than Strattice [OR: 19.5 (95% CI: 2.3-523.7) and p = 0.02]. However, in the observational cohort, the rate of 6-week SSO was similar for both XenMatrix (50.0%) and Strattice (33.3%) (p = 0.46) as well in the multivariate analysis [OR: 6.6 (95% CI: 0.4-324.6) and p = 0.23]. Finally, random effect meta-analysis of 6-week risk of SSO of both RCT and observational cohort showed that XenMatrix is associated with higher 6-week SSO risk than Strattice [OR: 12.5 (95% CI: 1.8-89.2) and I2 = 0% p = 0.012].

CONCLUSION

Our study showed that XenMatrix may be associated with higher risk of early SSO compared to Strattice. This underscores the importance of more head-to-head mesh comparison to optimize outcomes following VHR.

TRIAL REGISTRATION: NCT02228889 (www.

CLINICALTRIALS: gov).