A Comparative Effectiveness Research Study of a Bilayered Living Cellular Construct and a Viable Cryopreserved Placental Membrane for Use in Pressure Injuries

OBJECTIVES: Using real-world data (RWD) we conducted a comparative effectiveness analysis of a bilayered living cellular construct (BLCC)(a) versus a viable cryopreserved placental membrane (vCPM)(b) for the treatment of Pressure Injuries (PRIs). METHODS: Electronic medical records (WoundExpert®, Net Health, PA)(c) collected between 2017 and 2021 on 1,369 PRIs were analyzed. Ulcers 1-20 cm2 were included. Patients with no baseline wound measurements or follow-up visits were excluded. Evaluations were performed on 1,048 BLCC- and 321 vCPM- treated PRIs. A Cox analysis that adjusted for variables including ulcer area and duration was used to compute frequency and time to healing. The Hazard Ratio (HR) was computed to determine the probability of achieving healing throughout the study. RESULTS: Patient populations were well matched for patient demographics, wound characteristics, and treatment characteristics. The median time to healing was 126 days for vCPM and 103 days for BLCC. This difference between groups demonstrated a 18% reduction in time to healing with the use of BLCC; (p=0.0007). The frequency of healing for BLCC was significantly greater compared to vCPM at week 12 (42 vs 32%), 24 (64 vs 52%), and 36 (73 vs 62%); p=0.0007. The HR = 1.34 [95% CI (1.14, 1.61)]; p=0.0007. Treating PRIs with BLCC resulted in a 34% greater probability of healing compared to vCPM at each timepoint over the full period of observation in the study. CONCLUSIONS: These RWD analyses demonstrated that BLCC significantly improved healing compared to vCPM for the treatment of PRIs. BLCC RWD in PRIs showed consistent results when compared to data from pivotal RCTs that supported FDA approvals in VLUs and DFUs [1,2].