Comparison of Rectal Trumpet and Standard Care
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Clinical Comparison of the Rectal Trumpet and Standard Care in Acutely Ill Patients With Fecal Incontinence|
- Skin integrity
- Ease of use
- Cost effectiveness
- Patient comfort
|Study Start Date:||September 2005|
|Study Completion Date:||June 2007|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00307476
|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|