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Clinical Research
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Evaluation of two integrated outlets: summary of a multicenter, comparative, randomized, open, cross-over investigation Barbara Munson, RN, BSN, CWOCN, Julia Ringhofer, RN, BSN, CWOCN, Lorena Eckert, RN, BSN, CWOCN, Susan Wood, RN, PhD, Patrice Muse, RN, MSN, CWOCN, Cindy Fontana, RN, BS, CWOCN Background:.Handling aspects like ease of opening, closing and cleaning of the outlet are essential features of open-ended ostomy pouches. Various ostomy pouches with integrated outlets have been launched to ease daily living for people with ostomies. Purpose:.The main purpose of this investigation was to evaluate integrated outlet A* and integrated outlet B** with regard to handling aspects Objective: .Primary parameter was ease of Òhandling in generalÓ evaluated on a 5-point scale. Secondary parameters were related to handling, hygiene and preference Design:.This multi center, comparative, randomized, open, cross-over, investigation was conducted in the United States in the fall/ winter/ spring of 2004-2005. Pouches with outlet A and outlet B were tested for one week each. 36 subjects were included - main selection criteria: minimum 18 years old, having an colostomy, using a 2-piece open ended/drainable pouch, using a Òstandard-wearÓ adhesive, not currently/previously using an integrated outlet closure, not pregnant/breastfeeding. The investigation was approved by the appropriate IRBs Results:.Outlet A was evaluated significantly better than outlet B regarding Òhandling in generalÓ (P= 0.010). Furthermore, opening the outlet, opening the outlet with one hand only, emptying through the outlet, cleaning the outlet, hygiene of the outlet and preference among outlets were evaluated in significantly favour of outlet A (P values all below 0.05). No significant differences were found in favour of outlet B. All assessments were analyzed using ordinal logistic regression models and binomial tests (two sided significance level at 0.05) .Conclusion:.Outlet A is concluded to be superior to outlet B regarding handling, hygiene and preference *Pouch with outlet A: AssuraÒ EasiCloseTM WIDE Outlet.**Pouch with outlet B: New Image Lock Ôn RollTM |
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