A bilayered living skin construct (APLIGRAF) accelerates complete closure of hard-to-heal venous ulcers.

Abstract

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.

• Authors: V Falanga, M Sabolinski
• Journal: Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society (Wound Repair Regen) 1999 Jul-Aug Vol. 7 Issue 4 Pg. 201-7 ISSN: 1067-1927 [Print] United States
• PMID: 10781211 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Apligraf
• Collagen

Topics

• Adult
• Aged
• Aged, 80 and over
• Collagen
• Combined Modality Therapy
• Female
• Humans
• Male
• Middle Aged
• Pressure
• Prognosis
• Prospective Studies
• Skin, Artificial
• Varicose Ulcer (therapy)
• Wound Healing