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MA Healthcare, Journal of Wound Care, 3(13), p. 118-120, 2004

DOI: 10.12968/jowc.2004.13.3.26591

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Safety and performance of a new non-adhesive foam dressing for the treatment of diabetic foot ulcers

Journal article published in 2004 by M. Lohmann, J. K. Thomsen, M. E. Edmonds, K. G. Harding ORCID, J. Apelqvist, F. Gottrup
This paper is available in a repository.
This paper is available in a repository.

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Abstract

Objective: This study aimed to document the safety and performance of a new non-adhesive foam dressing (Biatain Non-adhesive Dressing, Coloplast A/S) in the treatment of established foot ulcers in patients with diabetes. Method: This was an open non-comparative prospective study. Participants had an ankle brachial pressure index score of over 0.4 (neuro-ischaemic) and an ulcer bigger than 1cm2 and less than 8cm2 in any direction. The treatment period was six weeks. Results: Thirty-five out of 37 patients completed the study. The mean wound area reduced from 5.4cm2 to 2.5cm2. Relative wound area reduced from 100% at baseline to 40% at week 6. ‘Wearing comfort’ improved throughout the study (p=0.039). Maceration remained stable or improved. None of the four reported adverse events were device related. Conclusion: This study demonstrates that treatment of diabetic foot ulcers with Biatain Non-adhesive Dressing results in considerable wound area reduction and prevents any deterioration in maceration. The dressing is safe and effective in the management of these ulcers. Declaration of interest: This study was support by Coloplast A/S, Humlebaek, Denmark.