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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 Wendy Fiorenzo, Janet Shafer, RN, BSN, CWOCN, Rose Konsel, RN, BSN, CWOCN, Raquel Branom, RN, BSN, CWOCN, Jean Crouch, RN, BSN, CWON, Cecilia Zamarripa, RN, BSN, CWOCN, Mary Montague, RN, BSN, CWOCN, Donna Loehner, BSN, CWOCN, Kerry Casey, BSN, 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 2004-2005. Pouches with outlet A and outlet B were tested for one week each. 32 subjects were included - main selection criteria: minimum 18 years old, having a colostomy, using a 2-piece open-ended/drainable pouch, using a Òstandard-wearÓ adhesive, not currently/previously using an integrated outlet closure, and not pregnant/breastfeeding. The investigation was approved by the appropriate IRBs Results:.No significant difference was found regarding Òhandling in generalÓ (P=0.078). However, outlet A was evaluated significantly better than outlet B regarding: folding/closing, security, comfort and preference (P-values all below 0.05). Overall, the pouch with outlet A was evaluated significantly better than the pouch with outlet B regarding discretion, comfort and preference (P values all below 0.05). No significant differences were found in favour of the pouch with 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 perspectives, feeling of security, and preference *Pouch with outlet A: Assura¨ EasiCloseTM WIDE Outlet.**Pouch with outlet B: SUR-FIT Natura¨ Invisiclose¨ |
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