OBJECTIVES: Using real-world data (RWD) we conducted a comparative effectiveness analysis of bilayered living cellular construct (BLCC)^(a) versus a cryopreserved cadaveric skin allograft (CCSA)^(b) for the treatment of Venous Leg Ulcers (VLUs).

METHODS: Electronic medical records (WoundExpert^®, Net Health, PA)^(c) collected between 2019 and 2022 on 10,220 VLUs were analyzed. Ulcers 1-40 cm² were included. Patients with no baseline wound measurements or follow-up visits were excluded. Evaluations were performed on 9,563 BLCC- and 657 CCSA- treated VLUs. 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 210 days for CCSA and 127 days for BLCC. This difference between groups demonstrated a 40% reduction in time to healing with the use of BLCC; (p<0.0001). The frequency of healing for BLCC was significantly greater compared to CCSA at week 8 (23 vs 19%), 12 (34 vs 28%), 18 (45 vs 38%), and 24 (53 vs 45%); p<0.0001. The HR = 1.31 [95% CI (1.17, 1.49)]; p<0.0001. Treating VLUs with BLCC resulted in a 31% greater probability of healing compared to CCSA at each timepoint over the entire study.

CONCLUSIONS: RWD analyses demonstrated that BLCC significantly improved healing compared to CCSA for the treatment of VLUs. These data may help guide VLU treatment practices. BLCC RWD in VLUs showed consistent results when compared to data from BLCC pivotal RCTs that supported FDA approval for use in VLUs and DFUs ^[1,2].