REAL WORLD DATA COMPARATIVE EFFECTIVENESS STUDY OF A BILAYERED LIVING CELLULAR CONSTRUCT AND A CRYOPRESERVED CADAVERIC SKIN ALLOGRAFT FOR THE TREATMENT OF PRESSURE INJURIES
Author(s)
Michael L. Sabolinski, MD1, Oscar Alvarez, PhD2;
1Sabolinski LLC, Franklin, MA, USA, 2Vascular and Wound Care Center, University Hospital, Rutgers, New Jersey Medical School, Department of Surgery Rutgers, Newark, NJ, USA
1Sabolinski LLC, Franklin, MA, USA, 2Vascular and Wound Care Center, University Hospital, Rutgers, New Jersey Medical School, Department of Surgery Rutgers, Newark, NJ, USA
OBJECTIVES: Using deidentified patient data from a wound specific electronic medical record (WoundExpert, NetHealth, PA) we compared the effectiveness of a bilayered living cellular construct (BLCC) to a cryopreserved cadaveric skin allograft (CCSA) for the treatment of pressure ulcers/pressure injuries (PIs) in a retrospective comparative effectiveness study.
METHODS: PIs over anatomical locations including sacrum, coccyx, greater trochanter, ischial tuberosity, calcaneus, and lateral malleolus were included. Data from 1,029 refractory PIs, Stages II-IV, with surface areas between 1 and 200 cm2 in size, treated between 2016 and 2025 at 245 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=785) compared to CCSA (n=244) were significantly greater by week 8 (30% vs. 22%), 12 (40% vs. 30%), 24 (58% vs. 46%), and 36 (67% vs. 55%); p=0.002. BLCC treatment significantly reduced the median time to wound closure by 35%, achieving healing 9 weeks sooner (17 vs. 26.0 weeks), p=0.002. Cox regression analysis showed that treatment with BLCC increased the probability of healing by 41% compared with CCSA. Hazard Ratio=1.41 [95% CI (1.13, 1.76)]; p=0.002.
CONCLUSIONS: These real-world data demonstrate that frequency, time, and probability of wound closure for BLCC-treated PIs were significantly improved when compared to CCSA-treated PIs. Data from real world comparative effectiveness assessments can guide clinicians to limit overuse of less effective therapies and underuse of more effective therapies. The PI RWD results using BLCC are comparable to pivotal RCT results that supported FDA approvals of BLCC for the treatment of VLUs and DFUs
METHODS: PIs over anatomical locations including sacrum, coccyx, greater trochanter, ischial tuberosity, calcaneus, and lateral malleolus were included. Data from 1,029 refractory PIs, Stages II-IV, with surface areas between 1 and 200 cm2 in size, treated between 2016 and 2025 at 245 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=785) compared to CCSA (n=244) were significantly greater by week 8 (30% vs. 22%), 12 (40% vs. 30%), 24 (58% vs. 46%), and 36 (67% vs. 55%); p=0.002. BLCC treatment significantly reduced the median time to wound closure by 35%, achieving healing 9 weeks sooner (17 vs. 26.0 weeks), p=0.002. Cox regression analysis showed that treatment with BLCC increased the probability of healing by 41% compared with CCSA. Hazard Ratio=1.41 [95% CI (1.13, 1.76)]; p=0.002.
CONCLUSIONS: These real-world data demonstrate that frequency, time, and probability of wound closure for BLCC-treated PIs were significantly improved when compared to CCSA-treated PIs. Data from real world comparative effectiveness assessments can guide clinicians to limit overuse of less effective therapies and underuse of more effective therapies. The PI 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
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
RWD26
Topic
Real World Data & Information Systems
Disease
SDC: Sensory System Disorders (Ear, Eye, Dental, Skin), STA: Biologics & Biosimilars