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Randomized Controlled Trial
. 2012 Oct;9(5):557-65.
doi: 10.1111/j.1742-481x.2011.00918.x.

IPARZINE-SKR study: randomized, double-blind clinical trial of a new topical product versus placebo to prevent pressure ulcers

Affiliations
Randomized Controlled Trial

IPARZINE-SKR study: randomized, double-blind clinical trial of a new topical product versus placebo to prevent pressure ulcers

José Verdú et al. Int Wound J. 2012 Oct.

Abstract

This study compared the efficacy of a new topical agent (IPARZINE-4A-SKR) on preventing category I pressure ulcers (PUs) over a 2-week period, compared with a placebo. A double-blind, randomised, multi-centre, placebo-controlled clinical trial in two parallel groups was conducted. The primary objective was to compare PU incidence between groups. Hospital and socio-sanitary centre patients (n = 194) at risk of developing a PU (Braden scale) were randomised into two groups. The intervention group included 99 patients, and the placebo group comprised 95 patients. Patients were comparable in terms of age, sex and PU risk. In both groups, patients had a high risk of developing PUs. The product was applied on the sacrum, trochanters and heels. Six PUs (incidence = 6·1%) were detected in the intervention group versus seven (incidence = 7·4%) in the placebo group. Differences were not statistically significant (z = 0·08; P = 0·94), relative risk = 0·82 (95% confidence interval = 0·29–2·36). The main limitation of the study was the sample size and, therefore, the main difficulty encountered was in determining whether the product is ineffective or simply has not been used with sufficient patients. In conclusion, it is not possible to confirm that there are any differences between the studied and the placebo treatments in the prevention of PUs. The results obtained were similar to those obtained in studies of PU prevention using products based on topical fatty acids.

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Figures

Figure 1
Figure 1
Kaplan–Meier curves.

References

    1. Hibbs P. The economics of pressure ulcer prevention. Decubitus 1998;1:32–8. - PubMed
    1. Torra JE. Valorar el riesgo de presentar una úlcera por presión. Escala de Braden. Rev Rol Enf 1997;224:23–30. - PubMed
    1. Grupo Nacional para el Estudio y Asesoramiento en Úlceras por Presión. Directrices Generales para la Prevención de las Úlceras por Presión [WWW document]. Logroño, 2002. URL www.gneaupp.org.
    1. Grupo Nacional para el Asesoramiento en Úlceras por Presión y Heridas Crónicas . Documentos GNEAUPP. Directrices para el tratamiento de úlceras por presión [WWW document]. GNEAUPP, Logroño, 2002. URL www.gneaupp.org.
    1. Ramon C, Salvador C, Torra JE. Evaluación de la utilización sistemática de un parque de superfícies especiales para el manejo de la presión en una UCI. Enferm Intensiva 2000;11: 118–26. - PubMed

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