title: ECAMulticapa: Effectiveness of double-layered compression therapy for healing venous ulcers in primary care: a Study Protocol.
abstract: BACKGROUND
  Chronic 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.
  
  
  METHODS
  Randomised, 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.
  
  
  CONCLUSIONS
  The 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.
  
  
  BACKGROUND
  This study has been recorded in the Clinical Trials.gov site with the code NCT02364921. 17 February 2015.
authors.affiliation: Centro de Salud La Paz, Atención Primaria, Servicio madrileño de Salud, Avenida Parque de Asturias s/n, Rivas-Vaciamadrid, 28523 Madrid Spain.
authors.forename: Carmen
authors.identifier: 0000-0002-3600-2791
authors.initials: C
authors.lastname: Folguera-Álvarez
authors.affiliation: Red de investigación en Servicios de salud en enfermedades crónicas (REDISECC), Unidad de Apoyo a la Investigación, Gerencia de Atención Primaria Madrid, Calle Hacienda de Pavones, 271-28030 Madrid, Spain.
authors.forename: Sofia
authors.initials: S
authors.lastname: Garrido-Elustondo
authors.affiliation: Facultad de Ciencias de la Salud, Departamento de Enfermería Comunitaria, Medicina Preventiva, Salud Pública e Historia de la Ciencia, Universidad de Alicante, Campus de San Vicente del Raspeig, AP 99, San Vicente del Raspeig, 03080 Alicante Spain.
authors.forename: José
authors.initials: J
authors.lastname: Verdú-Soriano
authors.affiliation: Centro de Salud Villa de Vallecas, Atención Primaria. Servicio madrileño de Salud, Calle Fuentidueña, 12 28031 Madrid, Spain.
authors.forename: Diana
authors.initials: D
authors.lastname: García-García-Alcalá
authors.affiliation: Hospital Puerta de Hierro Majadahonda, Servicio madrileño de Salud, Calle Joaquín Rodrigo 2, Majadahonda, 28222 Madrid Spain.
authors.forename: Mónica
authors.initials: M
authors.lastname: Sánchez-Hernández
authors.affiliation: Centro de Salud Federica Montseny, Atención Primaria, Servicio madrileño de Salud, Avenida de la Albufera, 285-28038 Madrid, Spain.
authors.forename: Oscar German
authors.initials: OG
authors.lastname: Torres-de Castro
authors.affiliation: Centro de Salud Rafael Alberti, Atención Primaria, Servicio madrileño de Salud, Calle San Claudio 154 c/v León Felipe, 28038 Madrid, Spain.
authors.forename: Maria Luisa
authors.initials: ML
authors.lastname: Barceló-Fidalgo
authors.affiliation: Centro de Salud Pavones, Atención Primaria, Servicio madrileño de Salud, Calle Hacienda de Pavones, 271-28030 Madrid, Spain.
authors.forename: Olga
authors.initials: O
authors.lastname: Martínez-González
authors.affiliation: Centro de Salud La Paz, Atención Primaria, Servicio madrileño de Salud, Avenida Parque de Asturias s/n, Rivas-Vaciamadrid, 28523 Madrid Spain.
authors.forename: Lidia
authors.initials: L
authors.lastname: Ardiaca-Burgués
authors.affiliation: Dirección Asistencial Sureste, Atención Primaria, Servicio madrileño de Salud, Avenida de la Albufera, 285-28038 Madrid, Spain.
authors.forename: Carmen
authors.initials: C
authors.lastname: Solano-Villarrubia
authors.affiliation: Centro de Salud Paracuellos del Jarama, Atención Primaria, Servicio madrileño de Salud, Calle Chorrillo Alta, 26-28860 Paracuellos del Jarama, Madrid Spain.
authors.forename: Pilar Raquel
authors.initials: PR
authors.lastname: Lebracón-Cortés
authors.affiliation: Centro de Salud Buenos Aires, Atención Primaria, Servicio madrileño de Salud, Calle Pio Felipe, c/v Boada, c/v José Paulette, 28038 Madrid, Spain.
authors.forename: Carmen
authors.initials: C
authors.lastname: Molins-Santos
authors.affiliation: Residencia San Fernando, Consejería de Bienestar Social, Calle Ventura de Argumosa 4, 28830 San Fernando de Henares, Madrid Spain.
authors.forename: Mar
authors.initials: M
authors.lastname: Fresno-Flores
authors.affiliation: Hospital Clínico Universitario San Carlos, Calle del Prof Martín Lagos, S/N, 28040 Madrid, Spain.
authors.forename: Maria Carmen
authors.initials: MC
authors.lastname: Cánovas-Lago
authors.affiliation: Centro de Salud Arganda, Atención Primaria, Servicio madrileño de Salud, Calle Camino del Molino s/n, 28500 Arganda del Rey, Madrid Spain.
authors.forename: Luisa Fernanda
authors.initials: LF
authors.lastname: Benito-Herranz
authors.affiliation: Centro de Salud San Fernando II, Atención Primaria, Servicio madrileño de Salud, Plaza de Ondarreta, 28830 San Fernando de Henares, Madrid Spain.
authors.forename: Maria Teresa
authors.initials: MT
authors.lastname: García-Sánchez
authors.affiliation: Centro de Salud Villablanca, Atención Primaria, Servicio madrileño de Salud, Calle Villablanca, 81 28032 Madrid, Spain.
authors.forename: Olga
authors.initials: O
authors.lastname: Castillo-Pla
authors.affiliation: Centro de Salud Villarejo de Salvanés, Atención Primaria, Servicio madrileño de Salud, Calle Hospital, 7-28590 Villarejo de Salvanés, Madrid Spain.
authors.forename: María Sol
authors.initials: MS
authors.lastname: Morcillo-San Juan
authors.affiliation: Centro de Salud Artilleros, Atención Primaria, Servicio madrileño de Salud, Paseo de los Artilleros s/n, 28032 Madrid, Spain.
authors.forename: Maria Begoña
authors.initials: MB
authors.lastname: Ayuso-de la Torre
authors.affiliation: Centro de Salud Villa de Vallecas, Atención Primaria. Servicio madrileño de Salud, Calle Fuentidueña, 12 28031 Madrid, Spain.
authors.forename: Pilar
authors.initials: P
authors.lastname: Burgos-Quintana
authors.affiliation: Centro de Salud Mejorada del Campo, Atención Primaria, Servicio madrileño de Salud, Calle Ciudad de Paris, 22-28840 Mejorada del Campo, Madrid Spain.
authors.forename: Ana
authors.initials: A
authors.lastname: López-Torres-Escudero
authors.affiliation: Centro de Salud Torito, Atención Primaria, Servicio madrileño de Salud, Calle Camino de Vinateros, 140-28030 Madrid, Spain.
authors.forename: Gema
authors.initials: G
authors.lastname: Ballesteros-García
authors.affiliation: Centro de Salud Jose María Llanos, Atención Primaria, Servicio madrileño de Salud, Calle Cabo Machichaco c/v, Cabo Tarifa, 28018 Madrid Spain.
authors.forename: Piedad
authors.initials: P
authors.lastname: García-Cabeza
authors.affiliation: Centro de Salud Doctor Tamames, Atención Primaria, Servicio madrileño de Salud, Calle Alameda, 1-28820 Coslada, Madrid Spain.
authors.forename: Maria Ángeles
authors.initials: MÁ
authors.lastname: de Francisco-Casado
authors.affiliation: Unidad de Apoyo a la Investigación, Gerencia Asistencial de Atención Primaria de Madrid, Madrid, Spain.
authors.forename: Milagros
authors.initials: M
authors.lastname: Rico-Blázquez
keywords: Compression bandage; Nursing; Primary health care; Quality of life; Venous ulcer; Wound healing