Sabolinski ML, Archambault T, et al.
Journal of comparative effectiveness research. Date of publication 2024 Apr 1;volume 13(4):e230109.
1. J Comp Eff Res. 2024 Apr;13(4):e230109. doi: 10.57264/cer-2023-0109. Epub 2024
Feb 13.
Real-world data analysis of bilayered living cellular construct and fetal bovine
collagen dressing treatment for pressure injuries: a comparative effectiveness
study.
Sabolinski ML(1), Archambault T(2).
Author information:
(1)Sabolinski LLC, Managing Member, Department of Medicine, Franklin, MA 02038,
USA.
(2)Virtu Stat Ltd., Department of Statistics, North Wales, PA 19454, USA.
Aim: To determine the effectiveness of bilayered living cellular construct
(BLCC) versus a fetal bovine collagen dressing (FBCD) in pressure injuries
(PRIs). Methods: A real-world data study was conducted on 1352 PRIs analyzed
digitally. 1046 and 306 PRIs were treated with BLCC and FBCD, respectively.
Results: Cox healing for BLCC (n = 1046) was significantly greater (p < 0.0001)
at week 4 (13 vs 7%), 8 (29 vs 17%), 12 (42 vs 27%), 24 (64 vs 45%), and 36 (73
vs 56%). The probability of healing increased by 66%, (hazard ratio = 1.66 [95%
CI (1.38, 2.00)]; p < 0.0001. Time to healing was 162 days for FBCD and 103 days
for BLCC showing a 36% reduction in time to healing with BLCC; (p < 0.0001).
Conclusion: BLCC significantly improved healing of PRIs versus FBCD.
DOI: 10.57264/cer-2023-0109
PMCID: PMC11044950
PMID: 38348818 [Indexed for MEDLINE]
Conflict of interest statement: Competing interests disclosure ML Sabolinski
serves as Chief Medical Officer and Managing Member of Sabolinski LLC, Franklin,
MA, USA. ML Sabolinski serves as a paid consultant for Organogenesis. T
Archambault (Virtu Stat Ltd, PA, USA) served as principal statistician for this
study. The authors have no other competing interests or relevant affiliations
with any organization/entity with a financial interest in or financial conflict
with the subject matter or materials discussed in the manuscript apart from
those disclosed.
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