BMC Family Practice

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-Solà1*, Aina Soler Mieras2, Antònia M Tomàs-Vidal3 and GAUPP-Expert Panel

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.

Keywords: Pressure ulcers, Pressure sore, Hydrocolloid dressing, Polyurethane foam dressings, Healing process

* Correspondence: mguillen@ibsalut.caib.es 1Primary Health Care-Mallorca: Research Unit. Health Care Services of Balearic Isles, IB-Salut, Palma de Mallorca, Balearic Islands, Spain Full list of author information is available at the end of the article

© 2013 Guillén-Solà et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

Guillén-Solà et al. BMC Family Practice 2013, 14:196 Page 2 of 8 http://www.biomedcentral.com/1471-2296/14/196

Background Pressure ulcers (PrUs) are ischemic wounds in the skin and underlying tissues, caused by continuous pressure from friction or shearing between an external surface and a bone or cartilaginous surface. Long-standing pres- sure can reduce capillary blood flow and lead to cell death, necrosis and broken tissue, or to additional ser- ious complications, including osteomyelitis, sepsis, con- tractures, atrophy and psychological disorders [1,2]. These complications may delay mobilization and active rehabilitation, as well as reducing the ability of patients to live active and independent lives. PrUs can affect pa- tients in all health care settings, provoke pain and discom- fort, decrease quality of life and even increase morbidity and residence time in healthcare institutions [3,4]. PrUs can also increase direct and indirect healthcare

costs and provide a negative image of healthcare institu- tions, attributable to deficits in the quality of care, espe- cially since 95% of PrUs are preventable [1,2]. A national study has estimated that expenditures related to the onset of PrU amounts to approximately 5% of the annual health- care spending in Spain [3,4]. A national prevalence study in 2006 by the GNEAUPP

(Spanish acronym of National Group for the Study and Advice in Pressure Ulcers and Chronic Wounds) showed a wide variability in PrUs prevalence among types of insti- tutions. PrUs have been reported to occur in 3.73% of pa- tients in domiciliary care, 8.24% of hospitalized patients and 6.1% of patients in nursing homes. Moreover, 2.1% of patients with PrUs were aged 0 to 45 years, 6.4% were aged 46 to 64 years and 87.4% were aged ≥ 65 years [5]. Within each category, PrU incidence was very variable, ranging from 3-29% in hospitalized patients. Moreover, PrUs have been observed in 66% of elderly individuals (risk population) with femur fractures [4-7]. The European Pressure Ulcer Advisory Panel (EPUAP)