Air Fluidized Therapy (AFT) in Patients With Suspected Deep Tissue Injury (sDTI)
| Tracking Information | |
|---|---|
| First Received Date ICMJE | February 8, 2011 |
| Last Updated Date | February 10, 2011 |
| Start Date ICMJE | August 2010 |
| Primary Completion Date | February 2011 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
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 |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT01292980 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Air Fluidized Therapy (AFT) in Patients With Suspected Deep Tissue Injury (sDTI) |
| Official Title ICMJE | Air Fluidized Therapy Use in Patients Who Present With Suspected Deep Tissue Injury - a Case Series |
| 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. |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Not Provided |
| Sampling Method | Non-Probability Sample |
| Study Population | Patients who present to the hospital with SDTI |
| Condition ICMJE | Pressure Ulcers |
| Intervention ICMJE | 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 |
| Study Group/Cohort (s) | Not Provided |
| Publications * | Not Provided |
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|
| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 5 |
| Completion Date | February 2011 |
| Primary Completion Date | February 2011 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
| Gender | Both |
| Ages | Not Provided |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT Number ICMJE | NCT01292980 |
| Other Study ID Numbers ICMJE | CR-2009-08 |
| Has Data Monitoring Committee | No |
| Responsible Party | Catherine VanGilder, Hill-Rom |
| Study Sponsor ICMJE | Hill-Rom |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | Hill-Rom |
| Verification Date | February 2011 |
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|