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Evaluation of an Incontinence Product

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03023072
Recruitment Status : Terminated (Site no longer met criteria)
First Posted : January 18, 2017
Last Update Posted : February 8, 2018
Sponsor:
Information provided by (Responsible Party):
Hill-Rom

Study Description
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Brief Summary:
The purpose of this study is to determine if the sponsor's Incontinence Product reduces patient exposure time to a wet and/or soiled incontinence pad.

Condition or disease Intervention/treatment
Incontinence Other: Incontinence Detection System

Study Design
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Study Type : Observational
Actual Enrollment : 9 participants
Observational Model: Case-Control
Time Perspective: Prospective
Actual Study Start Date : January 2017
Actual Primary Completion Date : January 30, 2018
Actual Study Completion Date : January 30, 2018
Groups and Cohorts
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Group/Cohort Intervention/treatment
Phase 1
Subjects will use the incontinence pad with incontinence detection notifications turned on
 Other: Incontinence Detection System
Phase 2
Subjects will use the incontinence pad with incontinence notification turned off


Outcome Measures
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Primary Outcome Measures :
  1. Patient exposure time following an incontinence event [ Time Frame: Through study completion, an average of 6 months ]

Secondary Outcome Measures :
  1. Patient satisfaction surveys [ Time Frame: Through study completion, an average of 6 months ]
  2. Staff satisfaction surveys [ Time Frame: Through study completion, an average of 6 months ]
  3. Family/patient support member surveys [ Time Frame: Through study completion, an average of 6 months ]
  4. Incidence of incontinence associated skin irritation and breakdown issues [ Time Frame: Through study completion, an average of 6 months ]
  5. Incidence of pressure injuries [ Time Frame: Through study completion, an average of 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Acute Care Unit
Criteria

Inclusion Criteria:

  • English speaking/reading adults, age ≥ 18 years
  • Incontinent (fecal, urine, or dual incontinence)
  • Patients with dual incontinence who require use of a fecal management system (but no urinary catheter)
  • Absence of skin irritation, breakdown, and pressure injuries present in the buttocks, sacrum, and/or perineal areas at the time of enrollment; minor irritation may be acceptable at the discretion of the Study Investigator
  • Willing and able to provide written informed consent or legal authorized representative is willing and able to provide written informed consent

Exclusion Criteria:

  • Presence of skin irritation and/or breakdown including but not limited to IAD or pressure injuries present in the buttocks, sacrum, and/or perineal areas at the time of enrollment; minor irritation may be acceptable at the discretion of the study Investigator
  • Require use of an absorbent undergarment (e.g. Depends) or catheter as the primary incontinence management strategy
  • Is considered to be near death or requires hospice care
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03023072


Locations
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United States, Indiana
Parkview Regional Medical Center
Fort Wayne, Indiana, United States
Sponsors and Collaborators
Hill-Rom
More Information
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Responsible Party: Hill-Rom
ClinicalTrials.gov Identifier: NCT03023072    
Other Study ID Numbers: CR-CWS2016-001
First Posted: January 18, 2017    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No