Air Fluidized Therapy (AFT) in Patients With Suspected Deep Tissue Injury (sDTI)
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 Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Air Fluidized Therapy Use in Patients Who Present With Suspected Deep Tissue Injury - a Case Series|
- 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
|Study Start Date:||August 2010|
|Study Completion Date:||February 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
Device: AFT bed
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01292980
|United States, Texas|
|Harris Methodist Hospital|
|Ft. Worth, Texas, United States, 76104|