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

Abstract

ObjectiveTo 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. DesignRandomized multicentre controlled clinical trial. Location22 Primary Health Centers of Madrid. ParticipantsOver 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. InterventionsControl 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 measurementsPrimary outcome: complete healing at 12 weeks. Secondary outcomes: severity of ulceration, health-related quality of life, adverse events. Blind evaluation of the response variable. ResultsComplete 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. ConclusionsWe 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.