2005 Symposium on Advanced Wound Care | |
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Clinical Research
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Randomized cross-over comparison of adhesive-coupled colostomy pouching systems Kirsten Berg, ET, Triwalk, Germany; Heidi Seidler, ET, Hannover, Germany Ostomy pouching systems affect users’ well-being and quality of life. Few controlled trials compare their effectiveness. A prospective, randomized open-label, cross-over study compared clinical performance and patient preferences for two adhesive-coupled pouching systems during normal use: a gelatin/pectin-based skin barrier sealed to the pouch with Adhesive Coupling Technology™ (System E*) or a grooved base-plate wafer adhesive pouch coupling system (System A†). Consenting participants were randomly assigned to use one system for 5 skin barrier/wafer changes or up to 15 days, then the alternative system for a similar period. Participants rated each ostomy system’s performance on standardized scales after each use and at usage period end, reporting comparative preferences at study end. Thirty-nine participants used a total of 1645 pouches and 342 skin barriers reporting similar safety for both systems and more adequate pouch wear times with System E (P<0.01). Usage-period-end ratings significantly favored System E on 10 of 17 attributes (P<0.04); System A on none. More participants preferred System E on all seven study-end measures, five significantly: comfort, flexibility, wear time, ease of removal and overall performance (P<0.02). These participant-reported outcomes support evaluation and selection of products to help enhance ostomy-related well-being and quality of life. * Esteem synergy® Adhesive Coupling Technology™ ostomy system, ConvaTec, Princeton, NJ, USA. Esteem synergy and Adhesive Coupling Technology are registered trademarks of E. R. Squibb & Sons, L. L. C. † Assura® AC ostomy system, also called EasiFlex® in some countries, are both registered trademarks of Coloplast Corporation References Marquis P, Marrel A, Jambon B. Quality of life in patients with stomas: the Montreux study. Ost Wound Manage. 2003;49(2):48–55. Turnbull GB, Colwell J, Erwin-Toth P. Quality of life: pre, post, and beyond ostomy surgery. Ost Wound Manage. 2004;50(Suppl 7A):2S–12S. Burt-McAliley D, Eberhardt D, van Rijswijk L. Peri-stomal skin irritation in colostomy patients. Ost Wound Manage. 1994;40(6):28–37. |
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