OBJECTIVES: Using deidentified, patient data from a wound-specific electronic medical record (WoundExpert, Net Health, PA, US), we compared the effectiveness of a bilayered living cellular construct (BLCC) to a dehydrated human amnion/chorion membrane (dHACM) for the treatment of pressure ulcers (PRUs) in a retrospective comparative effectiveness (CER) study.

METHODS: PRUs over anatomical locations including sacrum, coccyx, greater trochanter, ischial tuberosity, calcaneus, and lateral malleolus were included. Data from 1,189 refractory PRUs, Stages II–IV, with surface areas between 1 and 200 cm² in size, treated between July 2014 and October 2019 at 188 wound care facilities across the US were analyzed. All treated PRUs that closed by <40% within 28 days of the first treatment application were included. Unadjusted time to event analyses were performed by the method of Kaplan-Meier (K-M), and adjusted analyses were performed using Cox’s proportional hazards regression (Cox).

RESULTS: Patient baseline demographics and wound characteristics were comparable between groups. Cox derived estimates of wound closure for BLCC (728 wounds) were significantly greater (p=0.0001; Wald Test) by weeks 12 (36% vs. 27%), 18 (51% vs. 39%), and 24 (59% vs. 47%) respectively, compared with dHACM (461 wounds). BLCC treatment significantly reduced the median time to wound closure by 21%, achieving healing 4.4 weeks sooner (17.0 vs. 21.4 weeks, p=0.0001; Wald Test). Cox regression analysis adjusting for multiple covariates including ulcer area, depth, and duration showed that treatment with BLCC increased the probability of healing by 38% compared with dHACM (Hazard Ratio=1.38 [95% confidence interval (1.17, 1.62)], p=0.0001).

CONCLUSIONS: These real-world data demonstrate that BLCC significantly improved wound closure compared to dHACM for the treatment of PRUs. The improvements in the probability, speed and the incidence of wound closure in VLUs treated with BLCC suggest a greater clinical benefit as well as a potential cost savings benefit.