Journal of wound care · 2004
Safety and performance of a new non-adhesive foam dressing for the treatment of diabetic foot ulcers.
Клиническое исследованиеСтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Lohmann M, Thomsen J K, Edmonds M E, Harding K G, Apelqvist J, Gottrup F
Аннотация
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 1 cm2 and less than 8 cm2 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 5.4 cm2 to 2.5 cm2. 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.
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 1 cm2 and less than 8 cm2 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 5.4 cm2 to 2.5 cm2. 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.
Предметные рубрики MeSH
Activities of Daily LivingAdultAgedAged, 80 and overBandages, HydrocolloidColloidsDenmarkDiabetic FootExudates and TransudatesFemaleHumansMaleMiddle AgedNursing AssessmentPolyurethanesProspective StudiesSafetySeverity of Illness IndexSkin CareSwedenTime FactorsTreatment OutcomeUnited KingdomWound Healing