Falanga V, Sabolinski M, et al.
Wound repair and regeneration : official publication of the Wound Healing Society [and] the Eur.... Date of publication 1999 Jul 1;volume 7(4):201-7.
1. Wound Repair Regen. 1999 Jul-Aug;7(4):201-7.
A bilayered living skin construct (APLIGRAF) accelerates complete closure of
hard-to-heal venous ulcers.
Falanga V(1), Sabolinski M.
Author information:
(1)Department of Dermatology, Boston University School of Medicine, MA, USA.
vfalanga@bu.edu
The efficacy of a bilayered, living skin construct (APLIGRAF(R) [Graftskin]) was
evaluated in patients (n = 120) with hard- to-heal venous leg ulcers of greater
than 1 year's duration. The study was prospective, randomized, and controlled.
Patients received Graftskin plus compression therapy, or standard compression
therapy (active control). Patients were evaluated for frequency and time to
complete (100%) wound closure. Treatment with Graftskin was significantly more
effective than active control in the percentage of patients healed by 6 months
(47% vs. 19%; p < 0.005) and the median time to complete wound closure (p <
0.005). Analysis with multivariate regression methods, adjusting for factors
generally thought to influence wound healing (duration, baseline area, depth,
location, fibrinous wound bed, and infection), showed that patients treated with
Graftskin were twice as likely to achieve complete wound closure by 6 months (p <
0.005), and over 60% more effective in achieving wound closure than active
control (p < 0.01). These data indicate that Graftskin is an effective treatment
for venous ulcers of greater than 1 year's duration.
PMID: 10781211 [Indexed for MEDLINE]