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

Pressure Ulcers Clinical Trial

Official title:

Air Fluidized Therapy Use in Patients Who Present With Suspected Deep Tissue Injury - a Case Series

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01292980
• Other study ID #: CR-2009-08
• Status: Completed
• Phase: N/A
• First received: February 8, 2011
• Last updated: February 10, 2011
• Start date: August 2010
• Est. completion date: February 2011

Study information

• Verified date: February 2011
• Source: Hill-Rom
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pressure Ulcer
• Pressure Ulcers

Intervention

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

Locations

Country	Name	City	State
United States	Harris Methodist Hospital	Ft. Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Hill-Rom

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of breakdown	This case series seeks to identify patients with suspected DTI and capture actual patient outcomes with AFT treatment	21 days	No