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

NCT ID: NCT00771238

Last Updated: 2024-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2010-01-31

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).

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.

Conditions

Pressure Ulcers

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

P500 Mattress

The new P500 Low Air Loss mattress will be used to replace the standard mattress for this study arm.

Group Type: EXPERIMENTAL

P500 Mattress

Intervention Type: DEVICE

Study mattress

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

P500 Mattress

Study mattress

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hill-Rom

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joyce Black, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

University of Nebraska Medical Center

Omaha, Nebraska, United States

Countries

United States

Other Identifiers

CR-0095

Identifier Type: -

Identifier Source: org_study_id