Human keratin matrix use and wound healing outcomes in post-acute care of pressure ulcers: Evidence from a Bayesian real-world study
DOI:
https://doi.org/10.63676/vt5yx857Keywords:
Pressure Ulcers, Wound Healing, keratin-based matrix, Bayesian Analysis, Real-world evidence, Chronic woundsAbstract
Aims: To evaluate the real-world effectiveness of a human keratin matrix (HKM) compared with standard of care (SOC) in promoting pressure ulcer (PU) healing among patients treated in post-acute care settings.
Methods: This observational comparative effectiveness study analyzed deidentified PU-level data from the LiftOff Registry, a national real-world database capturing post-acute wound care delivered in long-term acute care hospitals and skilled nursing facilities. PUs treated with HKM plus SOC were compared with those managed with SOC alone. Bayesian propensity score methods were used to reduce confounding and balance baseline demographic and clinical characteristics measured at PU identification. Healing—defined as complete epithelialization or closure—was modeled using Bayesian logistic regression with study arm and baseline PU stage as predictors. Treatment effects were summarized as posterior risk ratios (RR) with 95% highest density intervals (HDI) and posterior probabilities of benefit.
Results: Before matching, the SOC cohort included 9356 patients with 14,740 PUs (33.2% healed), while the HKM cohort included 58 patients with 81 PUs (54.3% healed). After matching, 161 PUs were analyzed (81 HKM; 80 SOC); most were Stage 3 or Stage 4. HKM treatment was associated with higher modeled probabilities of healing compared with SOC alone. The posterior mean RR for healing was approximately 1.6 (95% HDI ≈ 1.0–2.1), with a posterior probability of benefit (RR > 1) of approximately 99.4%.
Conclusion: In this real-world post-acute care cohort of patients with PUs, HKM use was associated with a high posterior probability of improved healing compared with SOC alone. These findings support HKM as an adjunctive therapy for complex or non-healing pressure ulcers in post-acute care settings.
References
Lan X, Tang Y, Huang Z, et al. Global, Regional, and National Burden of Pressure Ulcers From 1990 to 2021 and Projections Over the Next Decade: Results From the 2021 GBD Study. Wound Repair Regen. 2025;33(4):e70064. https://doi.org/10.1111/wrr.70064 DOI: https://doi.org/10.1111/wrr.70064
Järbrink K, Ni G, Sönnergren H, et al. The humanistic and economic burden of chronic wounds: a protocol for a systematic review. Syst Rev. 2017;6(1):15. https://doi.org/10.1186/s13643-016-0400-8 DOI: https://doi.org/10.1186/s13643-016-0400-8
McCarty SM, Percival SL. Proteases and Delayed Wound Healing. Adv Wound Care (New Rochelle). 2013;2(8):438-447. https://doi.org/10.1089/wound.2012.0370 DOI: https://doi.org/10.1089/wound.2012.0370
Trengove NJ, Stacey MC, MacAuley S, et al. Analysis of the acute and chronic wound environments: the role of proteases and their inhibitors. Wound Repair Regen. 1999;7(6):442-452. https://doi.org/10.1046/j.15249475x.1999.00442.x DOI: https://doi.org/10.1046/j.1524-475X.1999.00442.x
Gill SE, Parks WC. Metalloproteinases and their inhibitors: regulators of wound healing. Int J Biochem Cell Biol. 2008;40(6-7):1334-1347. https://doi.org/10.1016/j.biocel.2007.10.024 DOI: https://doi.org/10.1016/j.biocel.2007.10.024
Wu S, Carter M, Cole W, et al. Best practice for wound repair and regeneration use of cellular, acellular and matrix-like products (CAMPs). J Wound Care. 2023;32(Sup4b):S1-S31. https://doi.org/10.12968/jowc.2023.32.Sup4b.S1 DOI: https://doi.org/10.12968/jowc.2023.32.Sup4b.S1
Rouse JG, Van Dyke ME. A Review of Keratin-Based Biomaterials for Biomedical Applications. Materials (Basel). 2010;3(2):999-1014. https://doi.org/10.3390/ma3020999 DOI: https://doi.org/10.3390/ma3020999
Konop M, Rybka M, Drapała A. Keratin Biomaterials in Skin Wound Healing, an Old Player in Modern Medicine: A Mini Review. Pharmaceutics. 2021;13(12):2029. https://doi.org/10.3390/pharmaceutics13122029 DOI: https://doi.org/10.3390/pharmaceutics13122029
Sabino F, auf dem Keller U. Matrix metalloproteinases in impaired wound healing. Metalloproteinases In Medicine. 2015;2:1-8. https://doi.org/10.2147/MNM.S68420 DOI: https://doi.org/10.2147/MNM.S68420
Ramey-Ward AN, Smith S, Walthall H, Barrows TH. Human Keratin Matrices Suppress Matrix Metalloproteinase Activity to Support Wound Healing. Int J Mol Sci. 2024;25(23):12898. https://doi.org/10.3390/ijms252312898 DOI: https://doi.org/10.3390/ijms252312898
Serena TE, Cullen BM, Bayliff SW, et al. Defining a new diagnostic assessment parameter for wound care: Elevated protease activity, an indicator of nonhealing, for targeted protease-modulating treatment. Wound Repair Regen. 2016;24(3):589-595. https://doi.org/10.1111/wrr.12431 DOI: https://doi.org/10.1111/wrr.12431
Wilgus TA, Roy S, McDaniel JC. Neutrophils and Wound Repair: Positive Actions and Negative Reactions. Adv Wound Care (New Rochelle). 2013;2(7):379-388. https://doi.org/10.1089/wound.2012.0383 DOI: https://doi.org/10.1089/wound.2012.0383
Armstrong DG, Orgill DP, Galiano RD, et al. A multicentre clinical trial evaluating the outcomes of two application regimens of a unique keratin-based graft in the treatment of Wagner grade one non-healing diabetic foot ulcers. Int Wound J. 2024;21(9):e70029. https://doi.org/10.1111/iwj.70029 DOI: https://doi.org/10.1111/iwj.70029
Ramey-Ward AN, Chatelain R. Use of a novel human keratin matrix improves healing rates in diabetic lower extremity wounds. Wounds. 2024;36(6):183-188. https://doi.org/10.25270/wnds/23139 DOI: https://doi.org/10.25270/wnds/23139
Koullias G, Ramey-Ward AN. Human keratin matrix in addition to standard of care accelerates healing of venous ulcers: a case series. J Wound Care. 2024;33(11):842-848. https://doi.org/10.12968/jowc.2024.0248 DOI: https://doi.org/10.12968/jowc.2024.0248
Ellis S, Patel M, Pesek E, et al. Evaluation of a Human Keratin Wound Matrix as an Effective Wound Healing Therapy in Difficult- to-Heal Venous Leg Ulcers. Eplasty. 2023;23:QA10
Concato J, Shah N, Horwitz RI. Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med. 2000;342(25):1887-1892. https://doi.org/10.1056/NEJM200006223422507 DOI: https://doi.org/10.1056/NEJM200006223422507
Franklin JM, Schneeweiss S. When and How Can Real World Data Analyses Substitute for Randomized Controlled Trials?. Clin Pharmacol Ther. 2017;102(6):924-933. https://doi.org/10.1002/cpt.857 DOI: https://doi.org/10.1002/cpt.857
McCandless LC, Gustafson P, Austin PC. Bayesian propensity score analysis for observational data. Stat Med. 2009;28(1):94-112. https://doi.org/10.1002/sim.3460 DOI: https://doi.org/10.1002/sim.3460
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Data may be made available upon request upon approval by LiftOff Registry.
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