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Comparing process outcomes of a traditional platelet rich plasma protocol and a fully automated system generating a compacted 3-layered leucocyte and platelet rich fibrin.
Introduction: Growth factor containing blood-derived products have been developed over the last decades. These include platelet-rich plasma (PRP) and second and third-generation products. PRP has historically been based on several different protocols including single soft spin centrifugation and two-step protocols. It is well known that outcomes of these procedures are highly variable between protocols, patients and even operators1 A new fully automated procedure for generating a compacted 3-layered leucocyte and platelet-rich fibrin (C3L-L-PRF) has been developed and its clinical effectiveness for diabetic wound management is proven.2 The outcome consistency of this and traditional PRP was investigated.
Methods: Traditional PRP was made from 5 donors by a published3 low-speed centrifugation procedure and compared to the outcomes of a fully-automated process to produce a C3L-L-PRF*. Cell recoveries were determined by automated cell counting (Sysmex). Outcome consistencies were compared by statistical analysis.ResultsThe standardized manual PRP procedure resulted in a platelet recovery of 40.3 % whereas the automated system resulted in a 98.1 % platelet recovery. The coefficient of variance were 7.1% for traditional PRP and 1.0% for the automated process.
Discussion: Consistent process outcomes are the key to implementing new autologous treatment modalities. Processes with manual operator handling of blood components result in more variable outcomes. Process effectiveness and variability can affect treatment outcomes and consistencies. Using a fully automated system results in higher process efficiency and less outcome variability and increases the chances of consistent clinical outcomes.
References
1. Mazzucco, L., Balbo, V., Cattana, E., Guaschino, R., & Borzini, P. (2009). Not every PRP-gel is born equal. Evaluation of growth factor availability for tissues through four PRP-gel preparations: Fibrinet, RegenPRP-Kit, Plateltex and one manual procedure. Vox Sanguinis, 97(2), 110–118.
2. Game, F., Jeffcoate, W., Tarnow, L., Jacobsen, J. L., Whitham, D. J., Harrison, E. F., Ellender, S. J., Fitzsimmons, D., Löndahl, M., Dhatariya, K., Chant, H., Spyer, G., Donohoe, M., Uchegbu, E., Whitelaw, D., Nayar, R., Rossing, P., Gottlieb, H., Michelsen, M., … Russell, D. (2018). LeucoPatch system for the management of hard-to-heal diabetic foot ulcers in the UK, Denmark, and Sweden: an observer-masked, randomised controlled trial. The Lancet Diabetes and Endocrinology, 6(11), 870–878.
3. Knighton, D., Ciresi, K., Fiegel, V., Austin, L., & Butler, E. (1986). Classification and treatment of chronic nonhealing wounds. Successful treatment with autologous platelet-derived wound healing factors (PDWHF). Annals of Internal Medicine, 204(3), 322–329.
Trademark
*3C Patch® System, Reapplix Inc.