Real-World Retrospective Analysis Comparing a Bilayered Living Cellular Construct and a Fetal Bovine Collagen Dressing for Use in Venous Leg Ulcers

OBJECTIVES: Using real-world data (RWD) we conducted a comparative effectiveness analysis (CEA) of a Bilayered Living Cellular Construct (BLCC)^(a) versus a Fetal Bovine Collagen Dressing (FBCD)^(b) for the treatment of venous leg ulcers (VLUs).

METHODS: Electronic medical records (WoundExpert^®, Net Health, PA)^(c) collected between 2020 and 2022, on 8,355 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 8,096 BLCC- and 259 FBCD- 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 20.0 weeks for FBCD and 14.7 weeks for BLCC; p=0.002. This difference between groups demonstrated a 26.5% reduction in time to healing with the use of BLCC; p=0.002. The frequency of healing for BLCC was significantly greater compared to FBCD at week 8 (29% vs 24%), 12 (43% vs 36%), 24 (65% vs 56%), and 36 (75% vs 66%); p=0.004. The HR = 1.28 [95% CI (1.08, 1.52)]; p=0.004. Treating VLUs with BLCC resulted in a 28% greater probability of healing compared to FBCD at every timepoint over 36 weeks.

CONCLUSIONS: RWD analyses demonstrated that BLCC significantly improved healing compared to FBCD for the treatment of VLUs. These data may help guide decision-making in care of patients with VLUs. RWD results in BLCC- treated patients showed effectiveness comparable to pivotal RCT efficacy findings that supported FDA approval of BLCC for the treatment of VLUs.

(c) WoundExpert^®, Net Health, PA