1456

A comparative, open, randomized, multi-center, crossover clinical investigation of a new one-piece drainable pouching system vs. a similar one-piece pouching system

Catherine R. Ratliff, PhD, APRN-BC, CWOCN1, Beryl P. Evans, MS, RN, CWON2, Rebecca J. Smith, RN, CWON2, Elisabeth Naeger, RN, CWOCN3, Zoe Shepard, RN, BSN, CWOCN3, Joan Dalgaard, RN, CWOCN3, Cory A. Ercanbrack, RN, BS, CWOCN4, Lori J. Goucher, RN, BSN5, Julia M. Ringhofer, RN, BSN, CWOCN6, Linda Lipscomb, RN, BSN, CWOCN2, Byron V. Lipscomb, RN2, and Janet Stoia Davis, RN, CWOCN7. (1) University of Virginia, Associate Professor, Charlottesville, VA 22908, (2) The Pouch Place Inc., Enterostomal Therapist, (3) Medical West Health Care Center, Enterostomal Therapist, (4) Intermountain Health Care, McKay-Dee Hospital Center, Enterostomal Therapist, (5) Intermountain Health Care, McKay-Dee Hospital Center, Coordinator Wound and Ostomy Services, (6) Scripps Mercy Hospital, Enterostomal Therapist, (7) Stoia Consultants, Wound, Ostomy Continence Nurse, Riverside, CA 92508

Background: As the frequency of problems related to an ostomy pouching system may be relatively high1, there is a need for an improvement of existing ostomy pouching systems. The quality of life of a person with an ostomy is highly affected by the performance of the ostomy pouching system2.

Purpose: To evaluate the performance of a new one-piece drainable ostomy pouching system (Product A) and to compare the performance of the new pouching system to another one-piece pouching system (Product B) already known to the market.

Objectives: The primary parameter is the evaluation of the pouching system as a whole, measured on a 5-point scale from “very poor” to “very good”. The secondary parameters are performance of other components of the pouch, including the skin barrier, filter, outlet and the pouch in general.

Design: The investigation is comparative, open, randomized, crossover investigation among 7 centers in the United States in 2006. Forty-two subjects (³ 18 years of age) with a colostomy (³ 3 months since creation) will be enrolled to evaluate a new one-piece drainable ostomy pouching system (Product A) for two weeks and a comparable pouching system (Product B) for another two weeks. The subject and the investigator will complete a questionnaire. The subjects normally wear a 1-piece drainable pouch, and manage the pouch themselves. None are: pregnant or breast-feeding, users of a convex barrier, suffer from peristomal skin problems or are receiving chemotherapy or radiation therapy.

Results: The collection of data will be finalized in January 2007. Results will be available in March 2007

Product A: Coloplast SenSura one piece with EasiCloseTM Product B: Hollister Premier one piece with Lock n' RollTM

Financial Disclosure: The investigation was initiated and sponsored by Coloplast A/S.


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