[Effectiveness of double-layered compression therapy against crepe bandage for healing venous ulcers in primary care. Randomized clinical trial].

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.