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Sponsors and Collaborators: |
Christiana Care Health Services SePA Chapter of the American Association of Critical Care Nurses Wound Ostomy Continence Nurses Society and Hollister |
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Information provided by: | Christiana Care Health Services |
ClinicalTrials.gov Identifier: | NCT00307476 |
Primary: To determine the effectiveness of the rectal trumpet compared to the standard care in maintaining skin integrity in patients with fecal incontinence.
Hypothesis (H1): There will be no difference in the failure rates of rectal area skin integrity between subjects receiving the rectal trumpet and those receiving treatment as usual (staqndard care).
Secondary: To determine the ease of use, cost-effectiveness, and level of patient comfort with the rectal trumpet compared to the standard care in patients with fecal incontinence.
Secondary (exploratory) hypotheses:
There will be differences in the ease of use of the devices, costs of the devices, and patient comfort relative to the devices.
Condition | Intervention |
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Fecal Incontinence |
Device: Rusch Nasopharyngeal Airway |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Clinical Comparison of the Rectal Trumpet and Standard Care in Acutely Ill Patients With Fecal Incontinence |
Estimated Enrollment: | 100 |
Study Start Date: | September 2005 |
Study Completion Date: | June 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Delaware | |
Christiana Care Health Systems | |
Newark, Delaware, United States, 19718 | |
Christiana Care Health Systems-Wilmington | |
Wilmington, Delaware, United States, 19801 |
Principal Investigator: | Denise Netta-Turner, BSN | Christiana Care Health Systems |
Study ID Numbers: | 24200 |
Study First Received: | March 24, 2006 |
Last Updated: | December 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00307476 |
Health Authority: | United States: Institutional Review Board |
Fecal Incontinence Fecal Containment Devices Skin Integrity |
Signs and Symptoms Fecal Incontinence Digestive System Diseases Urologic Diseases Urination Disorders |
Gastrointestinal Diseases Urinary Incontinence Intestinal Diseases Rectal Diseases |
Urological Manifestations |