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

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. Identifier: NCT00771238
Recruitment Status : Completed
First Posted : October 13, 2008
Results First Posted : September 28, 2015
Last Update Posted : August 7, 2017
Information provided by (Responsible Party):

Brief 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).

Condition or disease Intervention/treatment Phase
Pressure Ulcers Device: P500 Mattress Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores

Arm Intervention/treatment
Experimental: P500 Mattress
The new P500 Low Air Loss mattress will be used to replace the standard mattress for this study arm.
Device: P500 Mattress
Study mattress

No Intervention: Standard of Care Mattress
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.

Primary Outcome Measures :
  1. Indicence of Pressure Ulcers [ Time Frame: at the end of study period (21 days) ]
    New pressure ulcers were assessed

Secondary Outcome Measures :
  1. Cost of Rental Beds [ Time Frame: End of study ]
    Cost was measured for Beds/Surfaces that are rented for Wound management / prevention purposes only

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT00771238

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United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-5330
Sponsors and Collaborators
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Principal Investigator: Joyce Black, PhD, RN University of Nebraska
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Responsible Party: Hill-Rom Identifier: NCT00771238    
Other Study ID Numbers: CR-0095
First Posted: October 13, 2008    Key Record Dates
Results First Posted: September 28, 2015
Last Update Posted: August 7, 2017
Last Verified: August 2015
Keywords provided by Hill-Rom:
pressure ulcers
Therapy mattresses
Incidence of pressure ulcers
Additional relevant MeSH terms:
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Pressure Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases