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

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

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.

Study Overview

• Status: Completed
• Conditions: Pressure Ulcers
• Intervention / Treatment: Device: AFT bed

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.

• Study Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• United States
  • Texas
    • Ft. Worth, Texas, United States, 76104
      • Harris Methodist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who present to the hospital with SDTI

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of breakdown	This case series seeks to identify patients with suspected DTI and capture actual patient outcomes with AFT treatment	21 days

Collaborators and Investigators

• Sponsor: Hill-Rom

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: February 8, 2011
• First Submitted That Met QC Criteria: February 9, 2011
• First Posted (Estimate): February 10, 2011

Study Record Updates

• Last Update Posted (Estimate): February 11, 2011
• Last Update Submitted That Met QC Criteria: February 10, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: Pressure ulcers; sDTI; Therapy surfaces; Mattresses; Deep Tissue Injury; pressure ulcer treatment
• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Pressure Ulcer
• Other Study ID Numbers: CR-2009-08