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

NCT00771238 | Completed Results

• 1 other identifier: CR-0095
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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).

Conditions

Pressure Ulcers

Keywords

pressure ulcers; Therapy mattresses; Incidence of pressure ulcers

Outcome Measures

Primary Outcomes (1)

• Indicence of Pressure Ulcers

  New pressure ulcers were assessed

  at the end of study period (21 days)

Secondary Outcomes (1)

• Cost of Rental Beds

  End of study

Study Arms (2)

P500 Mattress

EXPERIMENTAL

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

Device: P500 Mattress

Standard of Care Mattress

NO INTERVENTION

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.

Interventions

P500 Mattress DEVICE

Study mattress

P500 Mattress

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects admitted to the 850 Surgical ICU
• Subjects or their legal reprehensive able to provide written consent for study
• Subjects must be within the weight limits of the beds (70-500 lbs)
• Subjects who do not require a specialty bed (subjective assessment by wound team)
• Subjects are 19 years or older

You may not qualify if:

• Subjects that do not wish to participate
• Subjects thought to require a different mattress by current clinical bed protocols.
• Subjects who require pulmonary clearance therapy delivered by a pulmonary mattress.
• Subjects whose weight is outside of the limits of the bed system.
• Subjects who have already completed 3 days of this study protocol and are considered completed Subjects.

Sponsors & Collaborators

• Hill-Rom: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198-5330, United States

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Joyce Black, PhD, RN
• Organization: Nebraska Medical Center

JBlack@unmc.edu

402-559-6573

Study Officials

• Joyce Black, PhD, RN

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2008
• First Posted: October 13, 2008
• Study Start: November 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: September 5, 2024
• Results First Posted: September 28, 2015

Record last verified: 2024-09

Locations

US (1)