RT Journal Article
T1 ECAMulticapa: Effectiveness of double-layered compression therapy for healing venous ulcers in primary care: a Study Protocol
A1 Folguera Álvarez, María Del Carmen
A1 Garrido Elustondo, Sofia
A1 Verdú Soriano, José
A1 García García Alcalá, Diana
A1 Sánchez Hernández, Mónica
A1 Torres de Castro, Oscar German
A1 Barceló Fidalgo, Maria Luisa
A1 Martínez González, Olga
A1 Ardiaca Burgués, Lidia
A1 Solano Villarrubia, Carmen
A1 Lebracón Cortés, Pilar Raquel
A1 Molins Santos, Carmen
A1 Fresno Flores, Mar
A1 Cánovas Lago, Maria Carmen
A1 Benito Herranz, Luisa Fernanda
A1 García Sánchez, Maria Teresa
A1 Castillo Pla, Olga
A1 Morcillo San Juan, María Sol
A1 Ayuso de la Torre, Maria Begoña
A1 Burgos Quintana, Pilar
A1 López Torres-Escudero, Ana
A1 Ballesteros García, Gema
A1 García Cabeza, Piedad
A1 de Francisco Casado, Maria Ángeles
A1 Rico Blázquez, Milagros
AB BackgroundChronic venous insufficiency, in its final stage can cause venous ulcers. Venous ulcers have a prevalence of 0.5 % to 0.8 % in the general population, and increases starting at 60 years of age. This condition often causes increased dependency in affected individuals, as well as a perceived reduced quality of life and family overload.Local Treating chronic venous ulcers has 2 components: topically healing the ulcer and controlling the venous insufficiency. There is evidence that compressive therapy favours the healing process of venous ulcers. The studies we have found suggest that the use of multilayer bandage systems is more effective than the use of bandages with a single component, these are mostly using in Spain. Multilayer compression bandages with 2 layers are equally effective in the healing process of chronic venous ulcers as 4-layer bandages and are better tolerated and preferenced by patients. More studies are needed to specifically compare the 2-layer bandages systems in the settings where these patients are usually treated.Method/designRandomised, controlled, parallel, multicentre clinical trial, with 12 weeks of follow-up and blind evaluation of the response variable.The objective is to assess the efficacy of multilayer compression bandages (2 layers) compared with crepe bandages, based on the incidence of healed venous ulcers in individuals treated in primary care nursing consultations, at 12 weeks of follow-up.The study will include 216 individuals (108 per branch) with venous ulcers treated in primary care nursing consultations.The primary endpoint is complete healing at 12 weeks of follow-up. The secondary endpoints are the degree of healing (Resvech.2), quality of life (CCVUQ-e), adverse reactions related to the healing process. Prognosis and demographic variables are also recorder.Effectiveness analysis using Kaplan-Meier curves, a log-rank test and a Cox regression analysis. The analysis was performed by intention to treat.DiscussionThe study results can contribute to improving the care and quality of life of patients with venous ulcers, decreasing healing times and healthcare expenditure and contributing to the consistent treatment of these lesions.Trial registrationThis study has been recorded in the Clinical Trials.gov site with the code NCT02364921. 17 February 2015.
PB BioMed Central Ltd
SN 1472-6955
YR 2016
FD 2016-10-12
LK https://hdl.handle.net/20.500.14352/123430
UL https://hdl.handle.net/20.500.14352/123430
LA eng
NO Folguera-Álvarez C, Garrido-Elustondo S, Verdú-Soriano J, García-García-Alcalá D, Sánchez-Hernández M, Torres-de Castro OG, et al. ECAMulticapa: Effectiveness of double-layered compression therapy for healing venous ulcers in primary care: A Study Protocol. BMC Nursing. 2016;15(1).
NO Este estudio fue financiado por el PN de I+D+i 2013–2016 y el ISCIII – Subdirección General de Evaluación y Fomento de la Investigación, así como por fondos FEDER (PI13/01975). Ministerio de Economía y Competitividad
DS Docta Complutense
RD 18 dic 2025