Real-World Data Analyses of a Bilayered Living Cellular Construct and a Cryopreserved Cadaveric Skin Allograft for use in Pressure Injuries

OBJECTIVES: Real-world data (RWD) were used to conduct a comparative effectiveness research study (CER) of a bilayered living cellular construct (BLCC)(a) versus a cryopreserved cadaveric skin allograft (CCSA)(b) for the treatment of pressure injuries (PRIs). METHODS: Electronic medical records (WoundExpert, Net Health®, PA)(c) were collected between 2017 and 2021 on 1,238 patients demonstrating PRIs (889 BLCC-treated, and 349 CCSA-treated). Ulcers 1-20 cm2 were included. Patients with no baseline wound measurements or follow-up visits were excluded. Analyses were performed on 1,422 PRIs, 1,048 BLCC- and 374 CCSA- treated. A Cox analysis that adjusted for multiple factors and covariates including area and duration was used to determine frequency and time to healing. The Hazard Ratio (HR) was computed to evaluate the probability of achieving healing throughout the study. RESULTS: Patient populations were comparable for demographics, wound and treatment characteristics. The median time to healing was 133 days for CCSA and 103 days for BLCC. BLCC reduced the time to healing by 23% when compared to CCSA; p=0.007. The frequency of healing for BLCC was significantly greater compared to CCSA at week 12 (42 vs 33%), 24 (64 vs 56%), and 36 (73 vs 66%); p=0.007. The HR = 1.25 [95% CI (1.06, 1.49)]; p