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

Pressure Ulcers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00771238
• Other study ID #: CR-0095
• Status: Completed
• Phase: N/A
• First received: October 10, 2008
• Last updated: August 25, 2015
• Start date: November 2008
• Est. completion date: January 2010

Study information

• Verified date: August 2015
• Source: Hill-Rom
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pressure Ulcer
• Pressure Ulcers
• Ulcer

Intervention

Device:
• P500 Mattress
Study mattress

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Hill-Rom

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Indicence of Pressure Ulcers	New pressure ulcers were assessed	at the end of study period (21 days)	Yes
Secondary	Cost of Rental Beds	Cost was measured for Beds/Surfaces that are rented for Wound management / prevention purposes only	End of study	No