Body Fit With a Pouching System With Concave Contour for People With an Outward Peristomal Body Profile: Effects on Leakage, Wear Time, and Quality of Life: A Randomized Controlled Cross-Over Trial.

Abstract

The purpose of the study was to investigate the fit of a two-piece pouching system with a concave-shaped skin barrier on people with an outward peristomal body profile and its effect on leakage, wear time, and quality of life (QoL) related to using an ostomy product. Randomized, controlled, open-label, cross-over trial. The sample comprised 53 subjects with outward peristomal body profiles and problems with leakage of ostomy effluent from their pouching system. Participants were randomized to the concave two-piece pouching system or a comparator (two-piece pouching system with a flat skin barrier) for 3 weeks. Subjects were then crossed over to the opposite skin barrier for an additional 3 weeks. The study was conducted in Denmark, Norway, Germany, and the Netherlands; data were collected in multiple ambulatory clinics or during home visits. The primary end point was the ability of the skin barrier to fit body contours; secondary outcomes were leakage of effluent from the pouching system, wear time, and QoL related to using an ostomy product via the validated Ostomy-Q questionnaire. Primary comparisons between concave and comparator pouching systems were evaluated using proportional odds models and mixed models taking test period into account. Analysis included randomized subjects who had been exposed to at least one product and with information on at least one end point (full-analysis-set, n =52). The concave pouching system provided a better fit to body contours than the comparator (P<.001) and reduced the degree of leakage underneath the skin barrier (LS mean difference=-1.84, 95% CI -3.31 to -0.37; P =.016). Participants experienced fewer episodes of leakage outside the skin barrier when using concave versus comparator pouching system (13.0% vs. 26.7%, respectively). Participants reported significant improvements in QoL (LS mean difference=14.3; 95% CI 9.4 to 19.2; P <.001). No significant difference in wear time between skin barrier shapes was reported. Study findings indicate that a pouching system with a concave skin barrier achieved a better body fit on people with an outward peristomal body profile and resulted in fewer leakage incidents and higher QoL compared to using a pouching system with a flat skin barrier.