Real World Data Comparative Effectiveness Study of a Bilayered Living Cellular Construct and a Dehydrated Human Amnion Chorion Membrane for the Treatment of Pressure Injuries
Author(s)
Michael L. Sabolinski, MD1, Oscar Alvarez, PhD2.
1Sabolinski LLC, Franklin, MA, USA, 2Department of Surgery Rutgers, Vascular and Wound Care Center, University Hospital, Rutgers, New Jersey Medical School, Newark, NJ, USA.
1Sabolinski LLC, Franklin, MA, USA, 2Department of Surgery Rutgers, Vascular and Wound Care Center, University Hospital, Rutgers, New Jersey Medical School, Newark, NJ, USA.
OBJECTIVES: Using deidentified patient data from a wound specific electronic medical record (WoundExpert, NetHealth, PA)(a) we compared the effectiveness of a bilayered cellular construct (BLCC)(b) to a dehydrated human amnion chorion membrane (dHACM)(c) for the treatment of Pressure Injuries/Pressure Ulcers (PRIs) in a retrospective comparative effectiveness study.
METHODS: PRIs over anatomical locations including sacrum, coccyx, greater trochanter, ischial tuberosity, calcaneus, and lateral malleolus were included. Data from 1,051 refractory PRIs, Stages II-IV, with surface areas between 1 and 200 cm2 in size, treated between 2021 and 2023 at 270 US wound care facilities were analyzed. Unadjusted time to event analyses were performed by the method of Kaplan-Meier (K-M), and analyses that adjusted for variables including ulcer size and duration were performed by Cox proportional hazards regression (Cox).
RESULTS: Patient baseline demographics and wound characteristics were comparable between groups. Cox derived estimates of wound closure for BLCC (n=735) compared to dHACM (n=316) were significantly greater by week 8 (32% vs. 25%), 12 (42% vs. 34%), 24 (58% vs. 49%), and 36 (67% vs. 57%); p=0.008. BLCC treatment significantly reduced the median time to wound closure by 41%, achieving healing 11.4 weeks sooner (16.6 vs. 28.0 weeks), p=0.008. Cox regression analysis showed that treatment with BLCC increased the probability of healing by 32% compared with dHACM. Hazard Ratio=1.32 [95% CI (1.07, 1.62)]; p=0.008.
CONCLUSIONS: These real-world data demonstrate that the frequency, time, and probability of wound closure for BLCC-treated PRIs was significantly improved when compared to dHACM-treated PRIs. Data from real world comparative effectiveness assessments can guide clinicians to limit overuse of less effective therapies and underuse of more effective therapies. The PRI RWD results using BLCC are comparable to pivotal RCT results that supported FDA approvals of BLCC for the treatment of VLUs and DFUs.
METHODS: PRIs over anatomical locations including sacrum, coccyx, greater trochanter, ischial tuberosity, calcaneus, and lateral malleolus were included. Data from 1,051 refractory PRIs, Stages II-IV, with surface areas between 1 and 200 cm2 in size, treated between 2021 and 2023 at 270 US wound care facilities were analyzed. Unadjusted time to event analyses were performed by the method of Kaplan-Meier (K-M), and analyses that adjusted for variables including ulcer size and duration were performed by Cox proportional hazards regression (Cox).
RESULTS: Patient baseline demographics and wound characteristics were comparable between groups. Cox derived estimates of wound closure for BLCC (n=735) compared to dHACM (n=316) were significantly greater by week 8 (32% vs. 25%), 12 (42% vs. 34%), 24 (58% vs. 49%), and 36 (67% vs. 57%); p=0.008. BLCC treatment significantly reduced the median time to wound closure by 41%, achieving healing 11.4 weeks sooner (16.6 vs. 28.0 weeks), p=0.008. Cox regression analysis showed that treatment with BLCC increased the probability of healing by 32% compared with dHACM. Hazard Ratio=1.32 [95% CI (1.07, 1.62)]; p=0.008.
CONCLUSIONS: These real-world data demonstrate that the frequency, time, and probability of wound closure for BLCC-treated PRIs was significantly improved when compared to dHACM-treated PRIs. Data from real world comparative effectiveness assessments can guide clinicians to limit overuse of less effective therapies and underuse of more effective therapies. The PRI RWD results using BLCC are comparable to pivotal RCT results that supported FDA approvals of BLCC for the treatment of VLUs and DFUs.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
CO112
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
SDC: Sensory System Disorders (Ear, Eye, Dental, Skin), STA: Biologics & Biosimilars, STA: Genetic, Regenerative & Curative Therapies, STA: Multiple/Other Specialized Treatments