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Combination of hydrocolloid dressing and medical compression stocking versus Unna's boot for the treatment of venous leg ulcers
Koksal C, Bozkurt AK
Swiss Medical Weekly 2003 Jun 28;133(25-26):364-368
clinical trial
6/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Various therapeutic approaches have been developed to manage venous ulcers. In this study the effectiveness of a hydrocolloid dressing (Comfeel Ulcer Dressing) in comparison to the Unna boot, the prototype of rigid bandages, was evaluated. METHODS: DESIGN: Prospective, comparative study. SETTING: University hospital. PATIENTS: Sixty patients diagnosed with post-thrombotic chronic venous insufficiency with venous ulcers were randomly assigned to two groups of 30 patients. INTERVENTIONS: In group A, the Unna boot, and in group B, hydrocolloid dressing in addition to the elastic compression were used. MEASURES: The two groups were compared in terms of (1) complete healing, (2) weekly wound surface reduction, (3) time to complete healing, (4) performance characteristics (ease-of-use score), (5) pain during application and at home, (6) application time. RESULTS: The duration of the ulcers was 16.6 +/- 5.8 weeks in group A and 16.9 +/- 6.2 in group B (p > 0.05). Previous ulcer recurrence was 74% (20/27 patients) in group A and 73% (19/26 patients) in group B (p > 0.05). The initial ulcer size was 6.38 +/- 1.2 cm2 in group A and 6.19 +/- 0.8 cm2 in group B (p > 0.05). The complete healing rates were 74.07% (20/27) in group A and 80.76% (21/26) in group B (p > 0.05). The weekly wound surface reductions were 1.28 +/- 0.72 cm2/week and 1.16 +/- 0.38 cm2/week in groups A and B, respectively (p > 0.05). The ulcer healing time was 6.85 +/- 3.60 weeks in group A, whereas it was 6.65 +/- 3.31 weeks in group B (p > 0.05). Ease-of-use score was 9.04 +/- 2.38 in group A and 17.27 +/- 3.27 in group B and the difference was significant (p < 0.0001). A higher degree of pain was reported by the patients who were treated with the Unna boot, both during application (group A 3.69 +/- 1.35, group B 1.88 +/- 1.48, p < 0.0001) and at home (group A, 3.27 +/- 1.08, group B, 1.88 +/- 1.11, p < 0.0001). The average time spent on Unna boot changes was 150.59 +/- 34.73 min, compared to 134.54 +/- 43.39 min in group B (p > 0.05). CONCLUSIONS: These results demonstrate the superiority of hydrocolloid dressing plus elastic compression treatment in terms of patient convenience.

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