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Giornale Italiano di Dermatologia e Venereologia 2005 February;140(1):83-8

Copyright © 2005 EDIZIONI MINERVA MEDICA

language: English, Italian

Open-label evaluation of an alginates hydrogel in the treatment of leg ulcers

Lacarrubba F. 1, Patania L. 2, Micali G. 1

1 Dermatology Clinic University of Catania, Catania, Italy 2 Plastic and Reconstruction Surgery Clinic University of Catania, Catania, Italy


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Aim. The aim of this study was to preliminarily evaluate efficacy and tolerability of a new gel formulation in the treatment of difficult to heal leg ulcers.
Methods. From June to December, 2003 8 subjects (2 male and 6 female, mean age 61, range 39-79 years) affected by difficult-to-heal leg ulcers were enrolled: 3 with venous ulcers, 2 with postsurgical ulcers, 1 with post-traumatic ulcer, 1 with ulcers and progressive systemic sclerosis, and 1 with a pressure ulcer.
The test article was composed of an amorphous hydrogel containing 5% alginates and an antibacterial enzymatic complex (glycosidase and lactose-peroxidase). The treatment schedule consisted of daily application of the gel covered by a secondary non-adherent medication for 3 months.
Results. At the end of the study there was complete resolution in 5 cases and >50% improvement in 3 cases. Onset of wound healing response varied from 20 days to 3 months, with reduction of pain and no observed side effects. Advantages of the gel were: its ability to retain moisture, its significant absorbant properties, its antibacterial activity, conformability of the medication to the ulcer surface, reduction of pain associated with minimal to no trauma and its ease of use.
Conclusion. In conclusion our results, although preliminary, suggest that the tested product is well tolerated and capable of promoting wound healing in addition to protecting the wound from opportunistic infections.

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