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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01292980
Recruitment Status : Completed
First Posted : February 10, 2011
Last Update Posted : February 11, 2011
Information provided by:

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.

Condition or disease Intervention/treatment
Pressure Ulcers 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
Actual Enrollment : 5 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Air Fluidized Therapy Use in Patients Who Present With Suspected Deep Tissue Injury - a Case Series
Study Start Date : August 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores
U.S. FDA Resources

Intervention Details:
    Device: AFT bed
    All identified patients will receive a AFT bed for a maximum of 21 days or until discharge
    Other Name: Clinitron® Rite HiteTM bed

Primary Outcome Measures :
  1. Degree of breakdown [ Time Frame: 21 days ]
    This case series seeks to identify patients with suspected DTI and capture actual patient outcomes with AFT treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who present to the hospital with SDTI

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01292980

United States, Texas
Harris Methodist Hospital
Ft. Worth, Texas, United States, 76104
Sponsors and Collaborators

Responsible Party: Catherine VanGilder, Hill-Rom Identifier: NCT01292980     History of Changes
Other Study ID Numbers: CR-2009-08
First Posted: February 10, 2011    Key Record Dates
Last Update Posted: February 11, 2011
Last Verified: February 2011

Keywords provided by Hill-Rom:
Pressure ulcers
Therapy surfaces
Deep Tissue Injury
pressure ulcer treatment

Additional relevant MeSH terms:
Pressure Ulcer
Skin Ulcer
Skin Diseases