Ignite Creation Date:
2024-05-05 @ 11:17 PM
Last Modification Date:
2024-10-26 @ 10:31 AM
Study NCT ID:
NCT01292980
Status:
COMPLETED
Last Update Posted:
2011-02-11
First Post:
2011-02-08
Brief Title:
Air Fluidized Therapy AFT in Patients With Suspected Deep Tissue Injury sDTI
Sponsor:
Hill-Rom
Organization:
Hill-Rom
Study Overview
Official Title:
Air Fluidized Therapy Use in Patients Who Present With Suspected Deep Tissue Injury - a Case Series
Status:
COMPLETED
Status Verified Date:
2011-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None