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

Not Applicable

Completed

• Conditions: Pressure Ulcers
• Interventions: Device: P500 Mattress

• Registration Number: NCT00771238
• Lead Sponsor: Hill-Rom

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.

Study Timeline

• Study First Submitted: 2008-10-10
• Study First Submitted QC: 2008-10-10
• Study First Posted: 2008-10-13
• Study Start: 2008-11
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Results First Submitted: 2015-03-23
• Status Verified: 2015-08
• Results First Submitted QC: 2015-08-25
• Results First Posted: 2015-09-28
• Last Update Submitted: 2017-07-07
• Last Update Posted: 2017-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Indicence of Pressure Ulcers	at the end of study period (21 days)	New pressure ulcers were assessed

Secondary Outcome Measures

Name	Time	Method
Cost of Rental Beds	End of study	Cost was measured for Beds/Surfaces that are rented for Wound management / prevention purposes only

Trial Locations

Locations (1)

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States