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Pilot Study of Incidence and Change in Existing Pressure Ulcers: TC500 Bed Compared With Standard Beds

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hill-Rom
ClinicalTrials.gov Identifier:
NCT00771238
First received: October 10, 2008
Last updated: March 20, 2012
Last verified: March 2012
History of Changes
  Purpose

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).


Condition Intervention
Pressure Ulcers
 Device: TC500
Device: Total Care Treatment mattress

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Pilot Study of Pressure Ulcer Incidence and Change in Existing Pressure Ulcers Comparing Subjects Placed on the TC500 Bed With Standard Beds in the 850-SICU Unit

Resource links provided by NLM:

MedlinePlus related topics: Pressure Sores
U.S. FDA Resources

Further study details as provided by Hill-Rom:

Primary Outcome Measures:
  • Indicence of pressure ulcers [ Time Frame: at the end of study period (21 days) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cost of rental beds [ Time Frame: End of study ] [ Designated as safety issue: No ]
  • Compliance to skin care protocol [ Time Frame: End of Study ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: November 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
TC500 bed patients
 Device: TC500
Study mattress
Active Comparator: 2
Standard of Care mattress
 Device: Total Care Treatment mattress
Standard of Care mattress

Detailed Description:

This single center convenience sample controlled study will admit all subjects admitted to the Cardiovascular Surgical ICU unit. Subjects can have up to a Stage III pressure ulcer (full thickness ulcer) if they are assessed by the clinical wound team not to require a specialty mattress. This 12 bed ICU will have 6 TC500 beds, and 6 existing Total Care beds. A waiver of consent is requested for initial bed placement, to accommodate normal bed assignments within the facility, however, informed consent will be obtained prior to the collection of data for study purposes. Consented subjects will have primary and secondary diagnoses recorded, as well as pressure ulcer risk assessments, assessment of ventilation / oxygenation support measures, and estimated cardiac condition. They will be followed by daily skin assessments until they reach one of the following study endpoints: 1) discharge from the 850 Cardiovascular SICU unit, 2) have skin breakdown, which in the clinical assessment of the wound team staff would require a specialty bed, 3) expire, 4) withdraw informed consent, or 5) complete the 21 day study period.

Subjects who experience either development of pressure ulcers, or worsening of their skin and/or existing pressure ulcers to the point where a specialty bed is deemed required by the wound team staff will be considered treatment failures, and will be placed on the appropriate mattress identified by the treating staff of the hospital for their admitted condition. If the mattress is a rental therapy mattress, an estimate of the costs to rent this product will be calculated for each patient moving onto a rental mattress.

An assessment of skin care protocol adherence will be performed by the Wound Care team on a daily basis where subjects will be audited as to the percent of prescribed measures implemented.

If subjects require rental therapy beds for pressure ulcer development, the costs associated with this rental will be estimated (# days x average dollar value). These costs will be compared between the rental groups.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects admitted to the 850 Surgical ICU
  2. Subjects or their legal reprehensive able to provide written consent for study
  3. Subjects must be within the weight limits of the beds (70-500 lbs)
  4. Subjects who do not require a specialty bed (subjective assessment by wound team)
  5. Subjects are 19 years or older

Exclusion Criteria:

  1. Subjects that do not wish to participate
  2. Subjects thought to require a different mattress by current clinical bed protocols.
  3. Subjects who require pulmonary clearance therapy delivered by a pulmonary mattress.
  4. Subjects whose weight is outside of the limits of the bed system.
  5. Subjects who have already completed 3 days of this study protocol and are considered completed Subjects.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00771238

Locations
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-5330
Sponsors and Collaborators
Hill-Rom
Investigators
Principal Investigator: Joyce Black, PhD, RN University of Nebraska
  More Information

No publications provided

Responsible Party: Hill-Rom
ClinicalTrials.gov Identifier: NCT00771238     History of Changes
Other Study ID Numbers: CR-0095
Study First Received: October 10, 2008
Last Updated: March 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Hill-Rom:
pressure ulcers
Therapy mattresses
Incidence of pressure ulcers

Additional relevant MeSH terms:
Pressure Ulcer
Ulcer
Skin Ulcer
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013