A Retrospective, Comparative Effectiveness Analysis of a Bilayered Living Cellular Construct and an Acellular Fetal Bovine Collagen Dressing in the Treatment of Venous Leg Ulcers

Abstract Body: Real-world effectiveness was evaluated in a large patient population comparing a bilayered living cellular construct (BLCC)(a) and an acellular fetal bovine collagen dressing (FBCD)(b) for the treatment of venous leg ulcers (VLUs). Wound care specific electronic medical records used by wound care facilities across the US were the source of these retrospective data(c). Treatment records collected between 1/2015 and 1/2019 on 6,916 patients (9,552 VLUs) were analyzed. Ulcers 1-40 cm2 that closed ≤40% in the 4 weeks prior to treatment were included. Key exclusion criteria included lack of baseline wound measurements or follow-up visits. Evaluations were performed on 6,648 BLCC patients (9,270 VLUs), and 268 FBCD patients (282 VLUs). At the first treatment application, median area was 6.8 cm2 and 7.1 cm2, and median durations were 5.1 and 5.5 months, for BLCC and FBCD, respectively. A Cox Proportional Hazards analysis adjusted for key covariates including ulcer size and duration was conducted on all available data in the timeframe evaluated. The median time to closure was significantly faster for BLCC (18 weeks) when compared to FBCD (25 weeks), representing a 28% reduction (p=0.003). The incidence of wound closure for BLCC was significantly greater compared to FBCD (p=0.003) by weeks 12 (35 vs 29%), 24 (54 vs 47%), and 36 (69 vs 52%), respectively. These data demonstrate that living cell-based BLCC compared to acellular FBCD significantly improved the time and frequency of wound closure of VLU patients in a real-world setting. (a) Apligraf®, Organogenesis Inc., Canton, MA (b) Primatrix®; Integra Life Sciences, Plainsboro Township, NJ (c) WoundExpert® (Net Health). De-identified patient data released to Organogenesis was consistent with the terms and conditions of Net Health System’s participating client contracts and the requirements of HIPAA. Net Health was not involved in the analysis or interpretation of the data.