Comparative effectiveness of a bilayered living cellular construct and a viable cryopreserved placental membrane for the treatment of pressure injuries

OBJECTIVES: Using deidentified, patient data from a wound-specific electronic medical record (WoundExpert(a), Net Health, PA, US), we compared the effectiveness of a bilayer living cellular construct(b) (BLCC) to a viable cryopreserved placental membrane(c) (vCPM) for the treatment of pressure injuries (PRIs) in a retrospective, comparative effectiveness (CER) study.
 

METHODS: PRIs over anatomical locations including sacrum, coccyx, greater trochanter, ischial tuberosity, calcaneus, and lateral malleolus were included. Data from 1,330 refractory PRIs, Stages II–IV, with surface areas between 1 and 200 cm2 in size, treated between March 2018 and March 2020 at 318 wound care facilities across the US were analyzed. All treated PRUs were included in a modified intent to treat (MITT) analysis. An unadjusted time to event (TTE) analysis was performed by the method of Kaplan-Meier (K-M), and an adjusted analysis was performed using Cox’s proportional hazards regression (Cox).

RESULTS: Patient baseline demographics and wound characteristics were comparable between groups. Cox derived estimates of percent wound closure for BLCC (1,034 wounds) was significantly greater (p=0.001) by weeks 12 (43 vs. 32%), 18 (56 vs. 45%), and 24 (64 vs. 52%), respectively compared with vCPM (296 wounds). K-M analysis showed a median time to wound closure for BLCC-treated wounds of 15 weeks compared to 17 weeks for vCPM-treated wounds; (p=0.001). Cox regression analysis adjusting for multiple covariates including ulcer area, depth, and duration showed that treatment with BLCC increased the probability of healing by 35% compared with vCPM (Hazard Ratio=1.35 [95% confidence interval (1.13, 1.61)], p=0.001).

CONCLUSIONS: These real-world data demonstrate that BLCC significantly improved wound closure compared to vCPM for the treatment of PRIs. The improvements in the probability, speed and the incidence of wound closure in PRUs treated with BLCC suggest greater clinical benefits as well as potential cost savings. 
(a) WoundExpert®, Net Health, Pittsburgh, PA. De-identified patient data. HIPPA compliant.
(b) Apligraf®, Organogenesis Inc, Canton, MA
(c) Grafix®; Osiris Therapeutics Inc., Columbia, MD

Trademarked Items (if applicable): (a) WoundExpert®, Net Health, Pittsburgh, PA. De-identified patient data. HIPPA compliant.
(b) Apligraf®, Organogenesis Inc, Canton, MA
(c) Grafix®; Osiris Therapeutics Inc., Columbia, MD

References (if applicable):