Randomized clinical trial of three-layer tubular bandaging system for venous leg ulcers.
The safety and efficacy of three-layer (3L) tubular bandaging as a treatment for venous ulcer healing has not been evaluated despite its use in many clinical settings to treat people with venous leg ulcers. We evaluated the safety and efficacy of 3L tubular bandage compared with short-stretch compression bandage to heal venous ulcers in a multicenter, open-label, parallel-group, randomized controlled trial. We randomized 45 patients with venous leg ulcers of up to 20 cm(2)  area and an ankle brachial pressure index of >0.8 from hospital outpatient wound clinics in Victoria and Queensland, Australia. We measured time to healing and percentage reduction of wound size from baseline to week 12. Secondary outcomes were proportion of ulcers healed, self-reported compliance of compression bandage, and health-related quality of life, costs, recurrence rates, and adverse events. A total of 27 ulcers healed, the proportion of healed ulcers was higher for the 3L group (17/23 [74%] vs. 10/22 [46%]) (p = 0.05). Reported bandage tolerance at all treatment visits was 21 (91%) in 3L group vs. 17 (73%) (p = 0.10). There was no difference between the groups in adverse events. Costs were substantially less in 3L group.
Centre of Research Excellence in Patient Safety, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia. carolina.weller@monash.edu
Carolina D
CD
Weller
Sue M
SM
Evans
Margaret P
MP
Staples
Pat
P
Aldons
John J
JJ
McNeil
D000368:Aged; D000369:Aged, 80 and over; D001458:Bandages; D015992:Body Mass Index; D005260:Female; D006801:Humans; D008297:Male; D010349:Patient Compliance; D017060:Patient Satisfaction / Q000706:statistics & numerical data; D017410:Practice Guidelines as Topic; D011793:Queensland / Q000453:epidemiology; D053828:Stockings, Compression; D016896:Treatment Outcome; D014647:Varicose Ulcer / Q000453:epidemiology / Q000503:physiopathology / Q000628:therapy*; D014739:Victoria / Q000453:epidemiology; D014945:Wound Healing