Expired Study
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Ft. Worth, Texas 76104


Purpose:

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 summary:

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.


Criteria:

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 is Available At:


Original ID:

CR-2009-08


NCT ID:

NCT01292980


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Hill-Rom


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Cohort, Time Perspective: P


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

5


Enrollment Type:

Actual


Study Dates

Start Date:August 2010
Completion Date:February 2011
Completion Type:Actual
Primary Completion Date:February 2011
Primary Completion Type:Actual
Verification Date:February 2011
Last Changed Date:February 10, 2011
First Received Date:February 8, 2011

Study Outcomes

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

Study Interventions

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

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Hill-Rom

Samples and Retentions

Study Population: Patients who present to the hospital with SDTI
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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