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Mattress
P500 Mattress for Bedsores
N/A
Waitlist Available
Led By Joyce Black, PhD, RN
Research Sponsored by Hill-Rom
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the end of study period (21 days)
Awards & highlights
No Placebo-Only Group
Summary
This pilot study will compare the incidence of pressure ulcers and the change in existing pressure ulcers for patients who are either placed on the new TC500 bed against those placed on the standard ICU bed in the Cardiovascular unit of University of Nebraska Medical Center. Additionally, the cost associated with rental beds will be calculated as well as skin care compliance. Sixty patients will be enrolled (30 per study arm).
Eligible Conditions
- Bedsores
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ end of study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of study
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Indicence of Pressure Ulcers
Secondary study objectives
Cost of Rental Beds
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: P500 MattressExperimental Treatment1 Intervention
The new P500 Low Air Loss mattress will be used to replace the standard mattress for this study arm.
Group II: Standard of Care MattressActive Control1 Intervention
Cardiovascular ICU patients that receive standard of care mattress (Total Care Treatment Mattress) and standard pressure ulcer prevention care. All patients had daily skin assessments, as per normal care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
P500 Mattress
2008
N/A
~60
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Who is running the clinical trial?
Hill-RomLead Sponsor
33 Previous Clinical Trials
2,790 Total Patients Enrolled
Joyce Black, PhD, RNPrincipal InvestigatorUniversity of Nebraska
1 Previous Clinical Trials
12 Total Patients Enrolled
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