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Randomized clinical trial of three-layer tubular bandaging ...

Randomized clinical trial of three -layer tubular bandagingsystem for venous leg ulcersCarolina D. Weller, MEd1; Sue M. Evans, PhD1; Margaret P. Staples, PhD2; Pat Aldons, MBBS, FRACP3;John J. McNeil, PhD41. Centre of Research Excellence in Patient Safety, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria,Australia,2. Department of clinical Epidemiology, Cabrini Hospital, Monash University, Melbourne, Victoria, Australia,3. Private Practice Wound Clinic, The Prince Charles Hospital, Brisbane, Queensland, Australia, and4.

Randomized clinical trial of three-layer tubular bandaging system for venous leg ulcers Carolina D. Weller, MEd 1; Sue M. Evans, PhD ; Margaret P. Staples, PhD2; Pat Aldons, MBBS, FRACP3; John J. McNeil, PhD4 1. Centre of Research Excellence in Patient Safety, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria,

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Transcription of Randomized clinical trial of three-layer tubular bandaging ...

1 Randomized clinical trial of three -layer tubular bandagingsystem for venous leg ulcersCarolina D. Weller, MEd1; Sue M. Evans, PhD1; Margaret P. Staples, PhD2; Pat Aldons, MBBS, FRACP3;John J. McNeil, PhD41. Centre of Research Excellence in Patient Safety, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria,Australia,2. Department of clinical Epidemiology, Cabrini Hospital, Monash University, Melbourne, Victoria, Australia,3. Private Practice Wound Clinic, The Prince Charles Hospital, Brisbane, Queensland, Australia, and4.

2 Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne,Victoria, AustraliaReprint requests:Dr. Carolina D. Weller, Department ofEpidemiology and Preventive Medicine,School of Public Health and PreventiveMedicine, Monash University, Level 6,The Alfred Centre, 99 Commercial Road,Melbourne Vic. 3004, :+61 3 990623;Fax:+61 3 990576;Email: clinical Trials RegistryNumber12608000599370 The Web address of clinical trial is: received: August 1, 2011 Accepted in final form: July 20, 2012 safety and efficacy of three -layer (3L) tubular bandaging as a treatment forvenous ulcer healing has not been evaluated despite its use in many clinical settingsto treat people with venous leg ulcers.

3 We evaluated the safety and efficacy of 3 Ltubular bandage compared with short-stretch compression bandage to heal venousulcers in a multicenter, open-label, parallel-group, Randomized controlled trial . Werandomized 45 patients with venous leg ulcers of up to 20 cm2area and an anklebrachial pressure index of> from hospital outpatient wound clinics in Victoriaand Queensland, Australia. We measured time to healing and percentage reduction ofwound size from baseline to week 12. Secondary outcomes were proportion of ulcershealed, self-reported compliance of compression bandage, and health-related qualityof life, costs, recurrence rates, and adverse events.

4 A total of 27 ulcers healed, theproportion of healed ulcers was higher for the 3L group (17/23 [74%] vs. 10/22[46%]) (p= ). Reported bandage tolerance at all treatment visits was 21 (91%) in3L group vs. 17 (73%) (p= ). There was no difference between the groups inadverse events. Costs were substantially less in 3L venous ulceration is extremely common and esti-mates have revealed venous leg ulcers (VLU) occur inapproximately of the general population in indus-trialized countries1with prevalence increasing with age,obesity, and natural history of VLUs is often acycle of healing and recurrence,3which has a considerableimpact on individual s health, quality of life (QoL)

5 , andsocioeconomic are the most common clinicalwound problem seen in general practice, and care is largelynurse led. The main treatment for VLU is a firm compressionbandage to aid venous ,6 High compression bandaging (30 40 mmHg) is an effec-tive treatment, healing over 70% of uncomplicated VLUs in systematic review of different compression ban-dages for venous ulcers concluded that the rate of ulcerhealing was increased with compression bandages when com-pared with no compression. It also found multicomponentsystems more effective than single-component systems, andthose with elastic bandages were more effective than inelasticsystems, but there were no clear differences in the effective-ness of different types of high different types of compression bandages are avail-able, and there is some evidence that nurses have difficultlydetermining which type to ,10 Two types of compressionbandaging are often used inAustralian community and generalpractice settings.

6 The short-stretch compression bandagesystem (SS) and the three -layered compression bandagingsystem (3L).11 The 3L bandage system is simple to apply, acomfortable alternative to standard compression bandages thatneed to be applied by a trained operator, are costly, and arehampered by patient ,12No studies have beenundertaken to assess the effectiveness or cost-effectiveness ofthe 3L bandage in achieving wound reduction and healingcompared with the SS bandage in people with VLUs eventhough the 3L is one of the most used compression purpose of this study was to assess the effectiveness,acceptability.

7 And cost of the SS compression bandage com-pared with the 3L bandage for the treatment of VLUs. Wehypothesized there would be no difference in wound sizereduction with 3L bandage system when compared with and settingsA multicenter, parallel-group, Randomized controlled trial wasconducted in four specialist wound clinics. Participants wereWound Rep Reg (2012) 2012 by the Wound Healing Society1recruited between February 2009 and January 2011 from hos-pital outpatient wound clinics in metropolitan settings in Vic-toria and Queensland, Australia.

8 Centers were recruited fromour known community of key specialist wound participants were aged over 18 years, ambulant,capable of giving informed consent, and of attending weeklyclinics. The VLU had to (1) have been be confirmed byclinical assessment; (2) have been present for at least 4 weeks;(3) have an area 1 and 20 cm2as measured by digitalplanimetry; (4) have an ankle brachial pressure index of mmHg; and (5) be on a leg with an ankle circumferenceof 20 to 30 were ineligible if they were participating inanother clinical trial , had evidence of severe liver disease,cardiac disease, chronic pulmonary disease, clinically sus-pected deep vein thrombosis, a medical condition likely torequire systemic corticosteroids during the study period, weresuffering from severe depression or psychiatric illness, or ifthey had suspected thrombophlebitis.

9 The study was approvedby Monash University, Alfred Health, Austin Health, Mel-bourne Health, and Queensland Health Human ResearchEthics was assessed and consent obtained by researchnurses at each site. Consenting participants were randomlyassigned 1 : 1 to one of the two groups via a web-basedsecure, central independent randomization service (nQueryv7, Statistical Solutions, Saugus, MA). Randomization wasstratified by study center and wound size. Where more thanone ulcer was present, the largest ulcer was used as the targetulcer and all ulcers treated with allocated treatment.

10 Becauseof the nature of the interventions, it was not possible to blindeither participants or study staff to Randomized to the intervention group received a3L straight bandage ( tubular -Form, Sutherland Medical,Oakleigh, Vic., Australia) applied in different lengths as out-lined in Figure 1. The first layer (long length) extended fromthe base of the toes to just under knee; the second layer(medium length) from base of toes to above calf pump, andfinally, the short third layer from base of toes to mid measurement determined the size of bandage in bothintervention and control Randomized to the control group received stan-dard SS compression therapy consisting of inelastic SS com-pression bandage (available in 8 cm and 10 cm width, 5 mlength Lastolan, Hartmann, Rhodes, NSW, Australia) appliedin a figure of eight and tubular retention to keep the inelasticbandage in place.


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