Atencion primaria · 2020
[Effectiveness of double-layered compression therapy against crepe bandage for healing venous ulcers in primary care. Randomized clinical trial].
СтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Folguera-Álvarez Carmen, Garrido-Elustondo Sofía, Rico-Blázquez Mili Milagros, Esparza-Garrido Miren Iranzu, Verdú-Soriano José, Grupo ECAMulticapa, Grupo ECAMulticapa
Аннотация
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.
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.