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.
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 cm(2) (median 2.3 cm(2)) 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 cm(2) (range = 0-9.6cm(2)). 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.
Bispebjerg University Hospital, Copenhagen, Denmark.
Bo
B
Jørgensen
Tonny
T
Karlsmark
Hanne
H
Vogensen
Lone
L
Haase
Rasmus
R
Lundquist
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001792:Blood Platelets; D002908:Chronic Disease; D016001:Confidence Intervals; D005260:Female; D005337:Fibrin; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D053657:Platelet-Rich Plasma; D011446:Prospective Studies; D012044:Regression Analysis; D055502:Secondary Prevention; D013223:Statistics as Topic; D014182:Transplantation, Autologous; D017211:Treatment Failure; D014481:United States; D014945:Wound Healing; D014947:Wounds and Injuries / Q000628:therapy*; D055815:Young Adult
D005337:Fibrin