A Pilot Study to Evaluate the Safety and Clinical Performance of Leucopatch, an Autologous, Additive-Free, Platelet-Rich Fibrin for the Treatment of Recalcitrant Chronic Wounds
| Autor: | Tonny Karlsmark, Hanne Vogensen, Lone Haase, Rasmus Lundquist, Bo Nørregaard Jørgensen |
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| Rok vydání: | 2011 |
| Předmět: |
Adult
Blood Platelets Male medicine.medical_specialty Adolescent Statistics as Topic Pilot Projects Transplantation Autologous Fibrin Young Adult Confidence Intervals Secondary Prevention Humans Medicine Autologous transplantation Prospective Studies Treatment Failure Prospective cohort study Adverse effect Aged Aged 80 and over Wound Healing biology Platelet-Rich Plasma business.industry General Medicine Middle Aged United States Confidence interval Platelet-rich fibrin Surgery Transplantation Chronic Disease biology.protein Regression Analysis Wounds and Injuries Female business Wound healing |
| Zdroj: | The International Journal of Lower Extremity Wounds. 10:218-223 |
| ISSN: | 1552-6941 1534-7346 |
| DOI: | 10.1177/1534734611426755 |
| Popis: | This prospective, uncontrolled pilot study evaluated the safety and clinical performance of Leucopatch an additive-free, autologous platelet-rich fibrin in the treatment of recalcitrant chronic wounds. Fifteen patients, with 16 lower extremity chronic wounds of varying etiologies were treated weekly with Leucopatch, prepared at the point of care from a donation of the patients’ blood, for 6 weeks, or until healing was complete. The wounds had been present for 2 to 108 months (median 24 months) and ranged in size from 0.4 to 15.7 cm2 (median 2.3 cm2) and had not responded to previous treatments. Of the 13 wounds (12 patients) included in the per-protocol efficacy analysis, 4 healed completely (31%). Mean wound area decreased significantly by 65% (95% confidence interval = 45.6% to 83.8%) resulting in a median wound size of 0.9 cm2 (range = 0-9.6cm2). There were no serious adverse events. Two adverse events, one of noncompliance and one infection, were observed; neither was considered to be related to treatment. The results indicate that Leucopatch is easy to prepare and apply in the clinic, is safe, and may be a clinically effective treatment of recalcitrant chronic wounds. |
| Databáze: | OpenAIRE |
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