Air Fluidized Therapy (AFT) in Patients With Suspected Deep Tissue Injury (sDTI)

NCT ID: NCT01292980

Last Updated: 2011-02-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2011-02-28

Brief Summary

Patients with a suspected Deep Tissue Injury (or a purple reddened area over a bony prominence of their body, which is expected to break down into a pressure ulcer) will be place on the Clinitron® Rite HiteTM bed to see if the air fluidized mattress decreases the amount of tissue breakdown from their bruise.

Detailed Description

Up to 15 centers will participate in this case series in acute care and long term acute care facilities. Patients who present with sDTI and consent for study will have the Clinitron® Rite HiteTM bed ordered and delivered within a 12 hour window to be able to participate. They will have their sDTI photographed, and an assessment of expected breakdown will be noted by the clinical team. The patient will be followed during the course of hospitalization and additional photographs and documentation will be performed by the clinical team to demonstrate the actual breakdown that occurred.

Information including the pertinent history of current illness, co-morbid conditions, and demographic information will be shared with the sponsor in order to demonstrate each case.

Conditions

Pressure Ulcers

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

AFT bed

All identified patients will receive a AFT bed for a maximum of 21 days or until discharge

Intervention Type: DEVICE

Other Intervention Names

Clinitron® Rite HiteTM bed

Eligibility Criteria

Inclusion Criteria

1. Patients with sDTI on the supine aspect of their body

2. Patient does not require a pulmonary specialty bed for care

3. Patient is expected to be in the hospital for at least 3 days

4. Patient weighs between 30 and 350 Lbs.

5. Patient's height is less than 75 inches tall

6. Patient, or patient's representative, is willing and able to sign written informed consent

7. Patient is expected to survive hospitalization.

Exclusion Criteria

1. Patient is less than 18 years of age

2. Patient has already participated in this study

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hill-Rom

INDUSTRY

Sponsor Role: lead

Responsible Party

Hill-Rom

Locations

Harris Methodist Hospital

Fort Worth, Texas, United States

Countries

United States

Other Identifiers

CR-2009-08

Identifier Type: -

Identifier Source: org_study_id