More venous leg ulcers are healed by three‐layer than by four‐layer paste bandages: a randomized clinical trial

Background: The aim of this study was to compare prospectively the number of ulcers healed, time to total healing and bandage tolerability of three‐ and four‐layer paste bandages. Methods: All patients with clinical evidence of venous ulceration were considered for the study. Ulcers were stratified by size into one of three groups and patients were randomized within each group to receive either three‐ or four‐layer paste bandages. Patients with diabetes, sickle‐cell disease, ankle: brachial pressure index less than 0·9, positive autoimmune serology, or ulcers smaller than 0·25 cm 2 or larger than 100 cm 2 in diameter were excluded. Complete ulcer healing was the only study endpoint. A venous aetiology was confirmed with duplex imaging, foot volumetry and venography. All patients were followed for 1 year and classified according to clinical manifestations, etiological factors, anatomic involvement and pathophysiological features (CEAP) criteria. Results: A total of 133 patients was entered into the study; 80 per cent of patients (51 of 64) receiving three‐layer bandages healed, compared with 65 per cent of those (45 of 69) having four layers ( P < 0·05, χ 2 test). This difference was apparent only after 16–20 weeks of treatment. The time to total healing increased with increasing ulcer size. Three‐layer paste bandages were quicker to apply and better tolerated than four layers. There were more post‐thrombotic legs in the four‐layer group (46 versus 38 per cent), but half‐refilling times did not differ significantly. These results were unaffected when analysis was restricted to confirmed venous ulcers. Conclusion: Three‐layer paste bandages are significantly more effective at healing venous ulcers than four‐layer bandages. They are also cheaper and better tolerated. Some 20–35 per cent of venous ulcers remain unhealed at 1 year despite adequate compression. © 2001 British Journal of Surgery Society Ltd