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Randomized clinical trial of different bandage regimens after foam sclerotherapy for varicose veins |
OHare JL, Stephens J, Parkin D, Earnshaw JJ |
The British Journal of Surgery 2010 May;97(5):650-656 |
clinical trial |
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; 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: This trial compared outcomes after foam sclerotherapy in patients wearing compression bandaging for 24 h or 5 days after treatment. METHODS: Consecutive patients with primary uncomplicated varicose veins were randomized after foam sclerotherapy treatment. The primary endpoint was 6-week Aberdeen Varicose Vein Severity Score (AVVSS) and Burford pain score. RESULTS: Some 124 legs were randomized, 61 to 24 h and 63 to 5 days of bandaging. Target vein occlusion rates at 6-week duplex imaging were 90 and 89% respectively (p = 0.842). There was no significant difference in phlebitis after 2 weeks (p = 0.445) or skin discoloration after 6 weeks (46 versus 40%; p = 0.546). There was no significant difference in the change in AVVSS from baseline to 2 weeks (-0.29 versus -0.80; p = 0.717) or to 6 weeks (-5.89 versus -5.14; 95% confidence interval (CI) for the difference -3.29 to 1.80; p = 0.563), or in change in Burford pain score from baseline to 2 weeks (-9.04 versus -2.80; p = 0.248) or to 6 weeks (-17.32 versus -8.46; 95% CI for the difference -19.06 to 1.33; p = 0.088), or in change in Short Form 36 score from baseline to 6 weeks (2.02 versus 1.74; p = 0.903). CONCLUSION: There was no advantage to compression bandaging for more than 24 h when thromboembolus deterrent stockings were worn for the remainder of 14 days. REGISTRATION NUMBER: NCT00991497 (http://www.ClinicalTrials.gov).
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