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A Journal on Physiopathology and Therapy of Chronic Cutaneous Ulcers
Official Journal of the Italian Association for Cutaneous Ulcers
Indexed/Abstracted in: EMBASE, Scopus, Emerging Sources Citation Index
Acta Vulnologica 2010 September;8(3):119-27
A prospective multicenter randomized controlled trial comparing the new 2-component bandage system Coban 2 with a zinc oxide bandage
Mosti G. 1, Crespi A. 2, Mattaliano V. 1
1 Reparto di Angiologia, Clinica MD Barbantini, Lucca, Italia;
2 S.S. Prevenzione e Cura Lesioni Vascolari, ASL NO, Novara, Italia
AIM: Compression therapy is the main treatment of the venous ulcers and has to be carried out by means of multicomponent, multilayer bandages providing strong pressure and high stiffness. The most widely used bandage is the Unna boot bandage. Aim of our work was to compare Unna boot with a new two-components bandage in terms of effectiveness and tolerability.
METHODS: A hundred patients affected by venous ulcers were enrolled in this study; for all the patients we used the same ulcer dressing and two different compression treatments: Unna boot was used in 50 patients, the new bandage in the other 50 patients, according to a randomized sequence. The patients were visited weekly to change the dressing and re-apply the bandages for three months and then monthly until healing. The following parameters concerning the ulcer and the bandage were considered: ulcer bed stage, ulcer surface and peri-wound skin, pain and quality of life, exerted pressure in supine and standing position both at application and removal, effect on leg edema, easiness of application and removal, adverse events.
RESULTS: The new bandage induced the ulcer healing in all the patients (47 out of 50) within the three months of the observation period. Compared with Unna boot it showed similar effectiveness (no statistically significant difference). The effect of compression on pain and quality of life is impressive: pain was reduced by half within 1, 2 weeks and remains at very low level for all the treatment period; quality of life was significantly improved. Despite of an exerted supine and standing pressure lower than Unna boot, the new bandage is able to maintain its pressure over time more effectively: the pressure values at removal time are very similar. The comfort provided by the bandage is good thanks to its high stiffness (median Static Stiffness Index 16 mm Hg); we did not report any drop-out due to adverse events.
CONCLUSION: Thanks to its strong pressure and high stiffness the new bandage seems to be very effective in inducing venous ulcers healing. The effect was not different from Unna boot so far considered as the “gold standard bandage” in compression therapy of venous ulcers. The new bandage is also highly tolerable and very easy to apply and remove and proved to be particularly indicated for the treatment of venous ulcers.