Efectividad de la terapia compresiva de doble capa frente al vendaje de crepé en la cicatrización de úlceras venosas en atención primaria. Ensayo clínico aleatorizado / Effectiveness of double-layered compression therapy against crepe bandage for healing venous ulcers in primary care. Randomized clinical trial

OBJETIVO: Evaluar si el vendaje de 2 capas es más efectivo que el vendaje de crepé en la cicatrización de úlceras venosas tras 12 semanas de seguimiento. DISEÑO: Ensayo clínico aleatorizado multicéntrico. Emplazamiento: 22 Centros de Salud de Madrid. PARTICIPANTES: Mayores de 18 años, con diagnóstico de úlceras venosas. Se aleatorizaron 93 pacientes, 56 en el grupo de doble capa y 37 en crepé. Retiradas: 16 en el grupo de doble capa y 7 en el de crepé. INTERVENCIONES: Grupo control: práctica clínica habitual: tratamiento de la herida y vendaje con crepé. Grupo experimental: misma práctica habitual para tratamiento de la herida y vendaje con doble capa. Mediciones principales: Variable respuesta principal: cicatrización completa a las 12 semanas. Variables secundarias: severidad de las lesiones, calidad de vida, reacciones adversas. Evaluación ciega de la variable respuesta. RESULTADOS: Cicatrización completa: 25 (67%) en el grupo crepé (IC al 95% 50,2-81,9) y 32 (57,1%) en doble capa (IC al 95% 43,2-70,3). Sin diferencias en ambos grupos, RR = 1,10 (IC al 95% 0,864-1,424). La severidad de las úlceras basales se asocia al tiempo de cicatrización, HR = 0,86 (IC al 95% 0,78-0,94). Se objetiva mejora significativa en la calidad de vida total y en las dimensiones cosmesis y estado emocional. No se encuentran diferencias según el vendaje utilizado. Sin reacciones adversas graves en ninguno de los grupos. CONCLUSIONES: No encontramos diferencias significativas en la cicatrización entre los 2 tipos de vendaje. Ambos son apropiados para la cicatrización de las úlceras y para mejorar la calidad de vida

OBJECTIVE: To evaluate if the two-layer bandage is more effective than the crepe bandage in the healing of venous ulcers after 12 weeks of follow-up. DESIGN: Randomized multicentre controlled clinical trial. LOCATION: 22 Primary Health Centers of Madrid. PARTICIPANTS: Over 18 years old, with diagnosis of venous ulcers. 93 patients were randomized, 56 in the double layer group and 37 in the crepe group. Withdrawals: 16 in double layer group, 7 in crepe group. INTERVENTIONS: Control group: usual clinical practice: treatment of the wound and bandage with crepe. Experimental group: same usual clinical practice for wound treatment and bandage with double layer. Main measurements. Primary outcome: complete healing at 12 weeks. Secondary outcomes: severity of ulceration, health-related quality of life, adverse events. Blind evaluation of the response variable. RESULTS: Complete healing: in crepe group, 25, 67.5% (95% CI 50.2-81.9) and in double layer group, 32, 57.1% (95% CI 43.2-70.3). No evidence of a difference in both groups, RR = 1.10 (95% CI 0.864-1.424). The basal severity of the ulcers is associated with the healing time. HR = 0.86 (95% CI 0.78-0.94). Our data showed a significant improvement in health-related quality of life, total and in the of cosmesis and emotional dimensions. No evidence of a difference in both groups. We didn't find serious adverse events in any of the groups. CONCLUSIONS: We didn't find significant differences in the healing between the two bandages evaluated. Both are appropriate for ulcer healing and to improve the health-related quality of life

[Effectiveness of double-layered compression therapy against crepe bandage for healing venous ulcers in primary care. Randomized clinical trial]. / Efectividad de la terapia compresiva de doble capa frente al vendaje de crepé en la cicatrización de úlceras venosas en atención primaria. Ensayo clínico aleatorizado.

OBJECTIVE: To evaluate if the two-layer bandage is more effective than the crepe bandage in the healing of venous ulcers after 12 weeks of follow-up. DESIGN: Randomized multicentre controlled clinical trial. LOCATION: 22 Primary Health Centers of Madrid. PARTICIPANTS: Over 18 years old, with diagnosis of venous ulcers. 93 patients were randomized, 56 in the double layer group and 37 in the crepe group. Withdrawals: 16 in double layer group, 7 in crepe group. INTERVENTIONS: Control group: usual clinical practice: treatment of the wound and bandage with crepe. Experimental group: same usual clinical practice for wound treatment and bandage with double layer. MAIN MEASUREMENTS: Primary outcome: complete healing at 12 weeks. SECONDARY OUTCOMES: severity of ulceration, health-related quality of life, adverse events. Blind evaluation of the response variable. RESULTS: Complete healing: in crepe group, 25, 67.5% (95% CI 50.2-81.9) and in double layer group, 32, 57.1% (95% CI 43.2-70.3). No evidence of a difference in both groups, RR=1.10 (95% CI 0.864-1.424). The basal severity of the ulcers is associated with the healing time. HR=0.86 (95% CI 0.78-0.94). Our data showed a significant improvement in health-related quality of life, total and in the of cosmesis and emotional dimensions. No evidence of a difference in both groups. We didn't find serious adverse events in any of the groups. CONCLUSIONS: We didn't find significant differences in the healing between the two bandages evaluated. Both are appropriate for ulcer healing and to improve the health-related quality of life.