A comparative effectiveness research study of a bilayered living cellular construct and a cryopreserved cadaveric skin allograft for use in venous leg ulcers

OBJECTIVES: Using real-world data (RWD) we conducted a comparative effectiveness analysis to study the heal rates of venous leg ulcers (VLUs) that were treated with either a bilayered living cellular construct (BLCC)(a) or a cryopreserved cadaveric skin allograft (CCSA)(b).

METHODS: Electronic medical records (WoundExpert, Net Health, PA)(c) collected between 2011 and 2019 on 7,127 patients (9,783 VLUs) were analyzed. Ulcers 1-40 cm2 that closed ≤40% in the 4 weeks prior to treatment were included. Patients with no baseline wound measurements or follow-up visits were excluded. Evaluations were performed on 6,579 BLCC patients (9,185 VLUs), and 548 CCSA patients (598 VLUs). A Cox analysis that adjusted for variables including ulcer area and duration was used to compute frequency, time to, and probability of wound closure.

RESULTS: Patient populations were comparable for patient demographics, wound characteristics, and treatment characteristics. The median time to healing was 18 weeks for BLCC and 29 weeks for CCSA showing a 38% reduction in time to healing with the use of BLCC; (p< 0.0001). The frequency of wound closure for BLCC was significantly greater compared to CCSA at all timepoints including week 8 (24 vs 19%), 12 (34 vs 27%), 18 (46 vs 38%), and 24 (54 vs 45%); p< 0.0001. The Hazard Ratio (HR) = 1.36 [95% CI (1.20, 1.54)]; p< 0.0001. Treating VLUs with BLCC-resulted in a 36% greater probability of healing compared to CCSA at every period of observation in the study.

CONCLUSIONS: The RWD shown here demonstrates that BLCC significantly improved the probability, speed, and incidence of healing when compared to CCSA. The value of real world evidence is magnified when it is supportive of previously conducted RCTs (1), thus, strengthening the proof of efficacy of BLCC in the treatment of difficult to heal VLUs.