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Interval Analysis of a Randomized, Open Label, Multi‐Center Study Comparing Apligraf Vs. Standard Multilayer Compression in the Reduction of Pain Associated WItH Venous Leg Ulcerations
Author(s) -
Serena T.,
Li V.W.
Publication year - 2008
Publication title -
wound repair and regeneration
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.847
H-Index - 109
eISSN - 1524-475X
pISSN - 1067-1927
DOI - 10.1111/j.1067-1927.2005.130216aw.x
Subject(s) - medicine , venous leg ulcer , randomized controlled trial , quality of life (healthcare) , clinical trial , visual analogue scale , confidence interval , surgery , physical therapy , nursing
Background: According to The American Pain Society, pain should be considered a fifth vital sign. Pain is a prominent feature of venous leg ulcerations (VLUs). Sixty‐five percent of VLU patients complain of severe pain. In several multicenter clinical trials, Apligraf, a bioengineered living skin construct, has been shown to accelerate healing in venous leg ulcerations. Anecdotal clinical observations suggest that Apligraf treatment is associated with pain relief. A treatment modality which promotes healing and reduces pain would significantly improve the quality of life in patients with VLU. Methods: VLU patients with pain scores greater than 5/10 on a numerical scale or requiring narcotic analgesia were randomized to receive either Apligraf and compression or compression alone. There was a 3‐week “wash‐out” period to ensure that pain was not due to other factors such as inadequate compression or infection. Patients were enrolled only after a negative quantitative biopsy. The intensity of pain was self‐scored and a quality‐of‐life questionnaire was completed at each visit. Weekly wound area measurements were obtained with digital planimetry. Results: Thus far in the enrollment period we have already seen a trend toward a significant reduction in pain in the Apligraf group. This pain relief occurs shortly after application indicating that a mechanism distinct from clinical healing. The Apligraf group also demonstrated acceleration in wound healing as well as a decreased time‐to‐complete closure. Conclusion: Interval analysis of this multicenter trial suggests that Apligraf accelerates wound healing and reduces the pain associated with venous leg ulcerations. Acknowledgment: Unrestricted Educational grant, Organogenesis Inc.