ear Readers: One challenge in managing venous insufficiency is encouraging patients to use appropriate compression consistently enough to aid venous return and reduce the edema associated with venous ulcer development or deterioration. Recent efforts to increase patient adherence to compression protocols have included use of elastic tubular bandages. This month’s Evidence Corner reviews 2 studies that illustrate clinical outcomes using tubular bandages in venous ulcer care. In the first study, a tubular bandage was compared to a short-stretch bandage as the primary source of compression as protocol in venous ulcer care. In the second carefully controlled study, tubular bandages served as the third outer layer when comparing zinc paste primary bandages overlaid with either elastic or inelastic bandages. The results of these studies raise interesting possibilities about options for care of venous ulcer patients.
Comparing a Tubular Compression Device with a Short-Stretch Bandage
Reference: Jünger M, Partsch H, Ramelet A, Zuccarelli F. Efficacy of a ready-made tubular compression device versus short-stretch compression bandages in the treatment of venous leg ulcers. WOUNDS. 2004;16(10):313–320.
Rationale: Compression bandages require expert application and may be poorly positioned or applied too loosely or too tightly resulting in poor adherence to the protocol of venous ulcer care and consequent delayed healing. Tubular bandages require less expertise to apply but have previously lacked the evidence base1 supporting their safety and efficacy in multilayer compression therapy for treating venous ulcers.
Objective: This open, randomized, international, multicenter study compared efficacy and safety of a tubular compression device versus a short-stretch compression bandage in ambulatory venous ulcer patients during 12 weeks of care.
Methods: All patients received standardized care including manual debridement, cleansing with physiological saline, application of absorbent, sterile, nonadherent gauze (not treated with an active pharmaceutical agent), occlusion of the ulcer, and an optional nonirritant protectant for surrounding skin lesions. Stratified within centers, subjects were randomly assigned to receive an outer layer of either an elastic tubular compression device or a short-stretch bandage. Devices and bandages were applied by experienced medical professionals according to the manufacturer’s instructions and were changed weekly for 12 weeks. Healing was evaluated at each device or dressing change.
Results: Complete healing was achieved in 58% of 88 tubular compression subjects and 56.7% of 90 short-stretch bandage subjects during the 12-week study period. There was no significant difference in likelihood of healing or time to complete healing for the 2 groups (median 42 days). Subject adherence to the compression protocol was good in the tubular compression group (96.8%) and in the short-stretch bandage group (96.4%). Both forms of compression were well tolerated, though patient complaints of pain or tightness in the compressed limb on the day after the first application of the tubular bandage led to use of larger size bandages in 12 tubular bandage subjects, who then proceeded to complete the study.
Conclusion: The results showed comparable efficacy between the ready-made tubular compression device and a short-stretch bandage in this study. The healing rates experienced in the relatively small, short-duration venous ulcers of the subjects in this study may be somewhat higher than would be expected in the general population.
Tubular Outer Bandages as Standardized Care for Venous Ulcers
Reference: Meyer FJ, Burnand KG, Lagattolla NR, Eastham D. Randomized clinical trial comparing the efficacy of two bandaging regimens in the treatment of venous leg ulcers. Br J Surg. 2002;89(1):40–44.
Rationale: Earlier research2 comparing elastic versus inelastic 3-layer bandages had used different outer retaining bandages for the 2 groups, raising the question of whether the effect arose from the elasticity of the compression layer or from differences in the outer layer retaining bandages.
Objective: This prospective, randomized, controlled study explored effects of an elastic versus an inelastic compression layer on venous ulcer healing within otherwise identical 3-layer bandages, both with a tubular retaining bandage as the third layer.
Methods: Venous ulcers stratified by size on enrollment were randomly assigned to 1 of 2 protocols of care including 3-layer compression applied by trained professionals using standard technique. Both compression techniques used a zinc-impregnated paste bandage as the primary layer on the wound and skin and an outer graduated cotton-elastic tubular retaining bandage as the third layer. The groups differed in that the mid-layer of 1 protocol was an elastic bandage (n=57), while the other mid-layer was inelastic (n=55). Treatment continued for 26 weeks or until healing, whichever came first, with a 40-week follow-up visit.
Results: Healing results were comparable at 26 weeks. In the group with elastic mid-layer plus elastic outer retaining bandage, 58% of patients healed in a mean of 10 weeks, while in the group with elastic only in the outer retaining bandage, 62% of patients healed in a mean of 11 weeks. Initial ulcer size greater than 25cm2 was a strong predictor of nonhealing for subjects with a venous ulcer in this study.
Conclusions: The authors concluded that there was little benefit to adding the middle elastic layer to multilayer elastic compression protocols of care for the legs of subjects with venous insufficiency ulcers. The authors recommend that future venous ulcer studies be stratified according to initial ulcer area.
Clinical Perspective
It appears that venous insufficiency ulcers heal in response to the moderate graduated compression provided by tubular bandages. The addition of a high compression layer appears to provide minimal healing benefits. Similar results (66% healed over a median of 4 months) were reported by Patel et al.3 in a cohort of 50 successive venous leg ulcer patients managed with 3 layers of tubular bandages (n=29). Lower healing rates were experienced in the groups using 2 layers (n=6) and 1 layer (n=2) of the tubular bandages. Six cases managed with other forms of compression including 4-layer bandages healed at rates comparable to those with 3-layer tubular compression. Moderate to high graduated, multilayer elastic compression appears to confer similar benefits for venous ulcer healing whether from bandages, stockings, or tubular compression devices.
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References
1. Cullum N, Nelson EA, Fletcher AW, Sheldon TA. Compression for venous leg ulcers. Cochrane Database Syst Rev. 2001;(2):CD000265.
2. Callam MJ, Harper DR, Dale JJ, et al. Lothian and Forth Valley Leg Ulcer Healing Trial, Part I: elastic versus non-elastic bandaging in the treatment of chronic leg ulceration. Phlebology. 1992;7:136–141.
3. Patel GK, Llewellyn M, Mellhuish J, Harding KG. Tubigrip® is an alternative and effective form of compression in the management of venous leg ulceration. Br J Dermatol. 2002;147(Suppl 62):28. |