Randomized clinical trial of three-layer paste and four-layer bandages for venous leg ulcers: Meyer FJ, McGuinness CL, Lagattolla NRF, et al. Br J Surg 2003;90:934-40

Abstract

ConclusionThree-layer compressive bandages are slightly more effective than four-layer compressive bandages for healing venous leg ulcers. SummaryOne hundred thirty-three patients with venous ulcers treated in a single clinic were stratified according to ulcer size and then randomized to receive three-layer or four-layer bandages. Ulcers were stratified by calculating the maximum length and breadth of the ulcer and multiplying these values. Ulcers were grouped into small (>0.25–<2.5 cm2), medium (2.5-25 cm2 ), and large (25-100 cm2 ) groups. Ulcers smaller than 0.25 cm2 or larger than 100 cm2 were excluded. Patients were excluded if they had diabetes, connective tissue disorders, rheumatoid arthritis, or human immunodeficiency virus, or were positive for sickle cell disease.Three-layer bandages consisted of a hypoallergenic paste, followed by a compression bandage, followed by Tubigrip. Four-layer bandages were comprised of orthopedic wool, a crepe bandage followed by a compressive bandage, and finally a Coban bandage. Patients were followed up for 1 year. Time to complete healing, defined as “restoration of entirely unbroken skin integrity without any purulent discharge after removal of all scabs,” was the primary end point.Complete ulcer healing occurred in 80% of patients treated with three-layer bandages and 65% of patients treated with the four-layer bandaging technique (P = .031). The median time to complete healing was 12 and 16 weeks, respectively (P = .04). The difference in healing did not become apparent until after 20 weeks of treatment. Large venous ulcers were less likely to heal. The adverse effect of ulcer size on healing was apparent in both the three-layer and four-layer bandage groups. Previous venous thrombosis or popliteal reflux did not affect ulcer healing. CommentBoth four-layer and three-layer bandaging techniques are effective in management of venous leg ulcers, with three-layer bandages apparently slightly more efficacious. Neither technique is suitable for all patients. In some patients allergy will develop to the paste component of the three-layer bandage, and other patients find the four-layer bandage bulky and uncomfortable. Not all forms of compression therapy are suitable for all patients. Physician and patient willingness to explore alternative management techniques is crucial to success of conservative therapy of venous ulcers.