Comparative effectiveness study of a bilayer cellular construct and dehydrated human amnion/chorion membrane in the treatment of pressure injuries.

Objective: Using real-world data, a comparative effectiveness analysis of a bilayer living cellular construct (BLCC) versus a dehydrated human amnion/chorion membrane (dHACM) for use in the treatment of pressure injuries (PIs) was conducted.

Method: Real-world data (RWD) in the form of electronic medical records of patients were analysed retrospectively. Patients with no baseline wound measurements or follow-up visits were excluded. Cox and Kaplan-Meier analyses were used to compute percentages and median times to healing, respectively.

Results: A total of 1764 PIs were analysed and evaluations performed on 1046 BLCC- and 718 dHACM-treated wounds. The Cox hazard ratio (HR) demonstrated the probability of healing over 36 weeks. Patient populations were comparable. The median time to healing was 19.0 weeks for dHACM and 14.7 weeks for BLCC (i.e., 22.6% reduction in time for BLCC); p<0.0001. The frequency of healing for BLCC versus dHACM was significantly greater at week 8 (29% versus 21%, respectively); at week 12 (42% versus 32%, respectively); at week 24 (64% versus 52%, respectively), and at week 36 (73% versus 62%, respectively); p<0.0001. The HR=1.37 (95% confidence interval: 1.21, 1.56); p<0.0001. BLCC-treated PUs had a 37% greater probability of healing compared to dHACM throughout the study.

Conclusion: In this study, findings showed that BLCC improved time, percentage of healed wounds and probability of healing PIs. RWD/comparative effectiveness analysis studies are beneficial to clinicians and help guide policymakers regarding reimbursement decisions.