Feasibility Study of a New Fistula Pouching System

Phase 2

Completed

• Conditions: Cutaneous Fistula

• Registration Number: NCT00294450
• Lead Sponsor: Coloplast A/S

Brief Summary

The purpose of this investigation is to carry out a clinical evaluation of a newly developed fistula pouching system's ability to function as a good pouch for fistulas, with the opening on the skin of the stomach or in a wound on the skin of the stomach.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-02-20
• Study First Submitted QC: 2006-02-20
• Study First Posted: 2006-02-22
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-31
• Last Update Posted: 2012-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• 18 years or older
• Capable of giving informed consent
• Have to be hospitalized
• Have a fistula with the opening on the skin in the abdominal area

Exclusion Criteria

• Pregnant and/or breast-feeding
• Receiving radiation- or chemotherapy during the investigation period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Nurse's preference to use the test product in the future	Up to 18 days

Trial Locations

Locations (7)

The Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Presbyterian Hospital of Dallas; 🇺🇸 Dallas, Texas, United States

Morton Plant Hospital; 🇺🇸 Clearwarter, Florida, United States

St. Francis Hospital and Medical Center; 🇺🇸 Hartford, Connecticut, United States

Fairview Southdale Hospital; 🇺🇸 Edina, Minnesota, United States

University of Minnesota Medical Center Fairview; 🇺🇸 Minneapolis, Minnesota, United States

University of Minnesota Medical Center Fairview - Riverside; 🇺🇸 Minneapolis, Minnesota, United States