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Randomized Controlled Trial
. 2013 Dec 21:14:196.
doi: 10.1186/1471-2296-14-196.

A multi-center, randomized, clinical trial comparing adhesive polyurethane foam dressing and adhesive hydrocolloid dressing in patients with grade II pressure ulcers in primary care and nursing homes

Mireia Guillén-Solà  1 , Aina Soler Mieras, Antònia M Tomàs-Vidal; GAUPP-Expert Panel
Collaborators, Affiliations
Randomized Controlled Trial

A multi-center, randomized, clinical trial comparing adhesive polyurethane foam dressing and adhesive hydrocolloid dressing in patients with grade II pressure ulcers in primary care and nursing homes

Mireia Guillén-Solà et al. BMC Fam Pract. .

Abstract

Background: Pressure ulcers (PrUs) are ischemic wounds in the skin and underlying tissues caused by long-standing pressure force over an external bone or cartilaginous surface. PrUs are an important challenge for the overall health system because can prolong patient hospitalization and reduce quality of life. Moreover, 95% of PrUs are avoidable, suggesting they are caused by poor quality care assistance. PrUs are also costly, increasing national costs. For example, they represent about 5% of overall annual health expenses in Spain. Stages I and II PrUs have a combined prevalence of 65%. According main clinical guidelines, stage II PrUs (PrU-IIs) are usually treated by applying special dressings (polyurethane or hydrocolloid). However, little scientific evidence regarding their efficacy has been identified in scientific literature. Our aim is to assess the comparative efficacy of adhesive polyurethane foam and hydrocolloid dressings in the treatment of PrU-IIs in terms of healed ulcer after 8 weeks of follow-up.

Methods/design: This paper describes the development and evaluation protocol of a randomized clinical trial of two parallel treatment arms. A total of 820 patients with at least 1 PrU-II will be recruited from primary health care and home care centers. All patients will receive standardized healing procedures and preventive measures (e.g. positional changes and pressure-relieving support surfaces), following standardized procedures. The main outcome will be the percentage of wounds healed after 8 weeks. Secondary outcomes will include cost-effectiveness, as evaluated by cost per healed ulcer and cost per treated patient and safety evaluated by adverse events.

Discussion: This trial will address the hypothesis that hydrocolloid dressings will heal at least 10% more stage II PrUs and be more cost-effective than polyurethane foam dressings after 8 weeks.

Trial registration: This trial has been registered with controlled-trials number ISCRCTN57842461 and EudraCT 2012-003945-14.

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References

    1. Conselleria de Salut i Consum. Grupo Asesor en Úlceras por Presión de Baleares, GAUPP. Prevención y tratamiento de las úlceras. : ; [Available on: http://www.caib.es]. [Consulted on November, 3rd 2010]
    1. Orlando PL. Pressure ulcer management in the geriatric patient. Ann Pharmacother. 1998;14(11):1221–1227. doi: 10.1345/aph.16482. - DOI - PubMed
    1. de Salud Carlos I III. Informe de evaluación de las tecnologías sanitarias. Efectividad de los apósitos especiales en el tratamiento de las úlceras por presión y vasculares: úlceras por presión. ISCIII. 2001;14:17–18. [Available on: http://www.isciii.es/htdocs/investigacion/publicaciones_agencia/28Ulcera...] [Consulted on November 3rd 2010.
    1. Gorecki C, Brown JM, Nelson EA, Briggs M, Schoonhoven L, Dealey C, Defloor T, Nixon J. European quality of life pressure ulcer project group. Impact of pressure ulcers on quality of life in older patients: a systematic review. J Am Geriatr Soc. 2009;14(7):1175–1183. doi: 10.1111/j.1532-5415.2009.02307.x. - DOI - PubMed
    1. Directrices para el tratamiento de las úlceras por presión. European Pressure Ulcer Advisory Panel (EPUAP) 1998. GNEAUPP Document. : ; http://www.gneaupp.org.

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