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

This study has been completed.
Sponsor:
Information provided by:
Hill-Rom
ClinicalTrials.gov Identifier:
NCT01292980
First received: February 8, 2011
Last updated: February 10, 2011
Last verified: February 2011

February 8, 2011
February 10, 2011
August 2010
February 2011   (final data collection date for primary outcome measure)
Degree of breakdown [ Time Frame: 21 days ] [ Designated as safety issue: No ]
This case series seeks to identify patients with suspected DTI and capture actual patient outcomes with AFT treatment
Same as current
Complete list of historical versions of study NCT01292980 on ClinicalTrials.gov Archive Site
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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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients who present to the hospital with SDTI

Pressure Ulcers
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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
February 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01292980
CR-2009-08
No
Catherine VanGilder, Hill-Rom
Hill-Rom
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Hill-Rom
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP