Status:
WITHDRAWN
Comparison of Rectal Trumpet and Standard Care
Lead Sponsor:
Christiana Care Health Services
Collaborating Sponsors:
American Association of Critical Care Nurses
Wound Ostomy Continence Nurses Society and Hollister
Conditions:
Fecal Incontinence
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 differ...
Detailed Description
Method: Subjects: A convenience sample of 80 adult male and female patients in the Wilmington Intensive Care Unit (WICU), Surgical Critical Care Center (SCCC), Medical Intensive Care Unit (MICU), an...
Eligibility Criteria
Inclusion
- Diarrhea - two episodes of loose or watery stool in a 12 hour period
- ≥ 18 years of age
- English-speaking patient or guardian
- Intact skin, may be reddened without breakdown
- Doctor's order for rectal trumpet if patient randomized to treatment group
Exclusion
- prolapsed anal sphincter
- active rectal bleeding
- colorectal cancer
- bleeding precautions
- rectal tone rated 1 (gaping) or 2 (lax)
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00307476
Start Date
September 1 2005
End Date
June 25 2007
Last Update
February 13 2023
Active Locations (2)
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1
Christiana Care Health Systems
Newark, Delaware, United States, 19718
2
Christiana Care Health Systems-Wilmington
Wilmington, Delaware, United States, 19801