Paula Erwin-Toth, MSN, RN, ET, CWOCN, CNS1, Barbara Hocevar, BSN, RN, ET, CWOCN2, Judy Landis-Erdman, BSN, RN, ET, CWOCN3, James Wu, MD4, G. Thomas Shires III, MD5, Shirley Dunbar, RN, BSN, CWOCN6, Anne Barnard, RN, BSN, CWOCN, CWS6, Catherine Skinner, RN, BS, CWOCN6, Diana Anderson, BSN, RN, CWOCN6, Susan Snyder, RN, BSN, WOCN7, Ann Navage, APRN, CWOCN8, Ellen Duell, APRN, CCRN, CWOCN9, Vicki Haugen, RN, MPH, CWOCN, OCN10, Julie Powell, RN, BSN, CWOCN10, Lea Hietala, RN, BSN, CWOCN11, Sandra Griffin, RN, BSN, CWOCN11, Cindy Owens, RN, BSN, MA, CWOCN7, and Cheryl Lynch, RNC, BSN, CWOCN7. (1) The Cleveland Clinic Foundation, Director, Enterostomal Therapy Nursing, Cleveland, FL 44195, (2) The Cleveland Clinic Foundation, Manager, Enterostomal Therapy / WOC Nursing, (3) The Cleveland Clinic Foundation, Enterostomal Therapist, (4) The Cleveland Clinic Foundation, Staff Surgeon, (5) Presbyterian Hospital of Dallas, Clinical Professor of Surgery, Dallas, 75205, (6) Presbyterian Hospital of Dallas, Wound Ostomy Continence Nurse, Dallas, TX 75231, (7) Morton Plant Health Care, Enterostomal Therapy Nurse, (8) Saint Francis Hospital and Medical Center, Wound Ostomy Continence Nurse, (9) Saint Francis Hospital and Medical Center, Clinical Nurse Specialist, (10) Fairview Southdale Hospital, Enterostomal Therapy Nurse, (11) University of Minnesota Medical Center Fairview, Wound Ostomy Continence Nurse
Background: Currently management of fistulas can be a very complicated and time-consuming process for the nursing staff. The lack of a functional pouch creates an inconvenience for patients and nurses relating to leakage, skin irritation, and mobility. Furthermore, the general wear time of existing pouching systems is considered to be inadequate.
Purpose: The purpose of this investigation is to investigate the performance of a new Fistula and Wound Management System and its ability to efficiently manage challenging fistula pouching situations.
Objective: The primary objective is to evaluate the nurse's preference, on a 4-point scale, to use the Fistula and Wound Management System in the future. The secondary objectives, among others, are to evaluate the performance: wear time, adaptation of pouch to fit the fistula/wound, flexibility of the adhesive, accessibility of the fistula/wound and features: Wound Trace Sheet, Drain Port and Bed Drainage Bag.
Design: The investigation is designed as a non-comparative, multi-center investigation. A maximum of 25 patients from ten centers in the United States will be included. Patients included must be at least 18 years old, capable of giving informed consent, hospitalized, and have an abdominal fistula. Patients are excluded if pregnant, breast-feeding or receiving radiation- or chemotherapy. The goal is that each patient tests five products. During the investigation, the Investigator will fill in a questionnaire with regard to the objectives listed above.
Results: The investigation is ongoing. The first patient was enrolled in January 2006. The last patient and conclusions are expected in spring 2007.
Financial disclosure: This investigation is initiated and sponsored by Coloplast A/S.
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See more of The WOCN Society 39th Annual Conference (June 9 -- 13, 2007)
