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 per cent 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 per cent; 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 per cent confidence interval (c.i.) 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 per cent c.i. 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). Copyright 2010 British Journal of Surgery Society Ltd.
RCT Entities:
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 per cent 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 per cent; 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 per cent confidence interval (c.i.) 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 per cent c.i. 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). Copyright 2010 British Journal of Surgery Society Ltd.