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Efectividad de la terapia compresiva de doble capa frente al vendaje de crepe en la cicatrizacion de ulceras venosas en atencion primaria. Ensayo clinico aleatorizado (Effectiveness of double-layered compression therapy against crepe bandage for healing venous ulcers in primary care. Randomized clinical trial) [Spanish; with consumer summary] |
Folguera-Alvarez C, Garrido-Elustondo S, Rico-Blazquez MM, Esparza-Garrido MI, Verdu-Soriano J, Grupo ECAMulticapa |
Atencion Primaria 2020 Dec;52(10):712-721 |
clinical trial |
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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 to 81.9) and in double layer group, 32, 57.1% (95% CI 43.2 to 70.3). No evidence of a difference in both groups, RR 1.10 (95% CI 0.864 to 1.424). The basal severity of the ulcers is associated with the healing time. HR 0.86 (95% CI 0.78 to 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.
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