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

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

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).

Study Overview

• Status: Completed
• Conditions: Pressure Ulcers
• Intervention / Treatment: Device: P500 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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68198-5330
      • University of Nebraska Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Indicence of Pressure Ulcers	New pressure ulcers were assessed	at the end of study period (21 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost of Rental Beds	Cost was measured for Beds/Surfaces that are rented for Wound management / prevention purposes only	End of study

Collaborators and Investigators

• Sponsor: Hill-Rom

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (ACTUAL): January 1, 2010
• Study Completion (ACTUAL): January 1, 2010

Study Registration Dates

• First Submitted: October 10, 2008
• First Submitted That Met QC Criteria: October 10, 2008
• First Posted (ESTIMATE): October 13, 2008

Study Record Updates

• Last Update Posted (ACTUAL): August 7, 2017
• Last Update Submitted That Met QC Criteria: July 7, 2017
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: pressure ulcers; Therapy mattresses; Incidence of pressure ulcers
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Ulcer; Pressure Ulcer
• Other Study ID Numbers: CR-0095