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112

Management of Fistulas in the Abdominal Region-A non-comparative, multi-center investigation

Cindy Owens1, Cheryl Lynch, RNC, BSN, CWOCN2, Marie Klaming RN, BSN, CWCN, COCN2, Vicki Haugen, RN, MPH, CWOCN, OCN3, Terri Garin, RN, BSN, CWOCN4, Julie Powell, RN, BSN, CWOCN5, Sandy Griffin, RN, BSN, CWOCN4, Lea Hietala, RN, BSN, CWOCN4, Cecillia Zamarripaca, RN, BSN, CWOCN6, Jean Crouch, RN, BSN, CWON7, Ann Navage, APRN, CWOCN8, Juliet Smith, RN, BSN, CWOCN9, and A. Chenel Trevellini, RN, BSN, WOCN10. (1) Morton Plant Mease Health Care, CWOCN, 323 Jeffords Street, Clearwater, FL 33756, (2) Mortin Plant, WOCN, 300 Pinellas Street, Clearwater, FL 33756, (3) Fairview Southdale Hospital, WOCN, 6401 France Avenue South, Edina, MN 55435, (4) University of Minnesota Medical Center Fairview, CWOCN, 420 Delaware Street South East, Minneapolis, MN 55455, (5) Fairview Southdale Hospital, CWOCN, 6401 France Avenue Room 400A, Edina, MN 55435, (6) University of Pittsburgh Medical Center, CWOCN, 200 Lothrop St, Pittsburgh, PA 15213, (7) University of Pittsburgh Medical Center, Enterstomal Therapy Nursing Department, CWON, 200 Lothrop Street, Pittsburgh, PA 15213, (8) St Francis Hospital, CWOCN, 114 Woodland St, Hartford, CT 06105, (9) New York Presbyterian Hospital, CWOCN, 177 Fort Washington Avenue, New York, NY 10032, (10) New York Presbyterian Hospital, WOCN, 177 Fort Washington Avenue, New York, NY 10032

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 demonstrate the functionality of a new Fistula/Wound Management System and its ability to efficiently manage challenging fistula pouching processes.

Objective: The primary objective is to evaluate the nurse's preference to use the Fistula/Wound Management System in the future. This evaluation is based on a 4-point scale.

The secondary objectives, among others, are to evaluate the functionalities: 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 Collection Bed Drainage Bag.

Design: The investigation is designed as a non-comparative, multi-center investigation. Ten centers in the United States are involved and a maximum of 25 patients 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 test five products. During the investigation, the Investigator will fill in a Case Report Form regarding the objectives listed above.

Data will be presented as case stories.

Time-schedule: The investigation is ongoing: · The first patient will be enrolled in January 2006. · Last patient is expected to complete the investigation in April 2006. · Conclusion and case stories are expected in May 2006.

Financial Assistance/Disclosure: This investigation is initiated and sponsored by Coloplast A/S.


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