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

Autor: J K Thomsen, Finn Gottrup, Keith G Harding, M Lohmann, Jan Apelqvist, Michael Edmonds
Rok vydání: 2004
Předmět:
Zdroj: Journal of Wound Care. 13:118-120
ISSN: 2052-2916
0969-0700
DOI: 10.12968/jowc.2004.13.3.26591
Popis: 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.
Databáze: OpenAIRE