Pressure UlcersNCT01292980
Air Fluidized Therapy (AFT) in Patients With Suspected Deep Tissue Injury (sDTI)
An observational study of Pressure Ulcers, run by Hill-Rom at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pressure Ulcers
- What is being tested?
- AFT bed
- Type of treatment
- Medical device
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Feb 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who present to the hospital with SDTI
Who may be able to join
- Patients with sDTI on the supine aspect of their body
- Patient does not require a pulmonary specialty bed for care
- Patient is expected to be in the hospital for at least 3 days
- Patient weighs between 30 and 350 Lbs.
- Patient's height is less than 75 inches tall
- Patient, or patient's representative, is willing and able to sign written informed consent
- Patient is expected to survive hospitalization.
Who cannot join
- Patient is less than 18 years of age
- Patient has already participated in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pressure Ulcers
- Being tested
- AFT bed
- Keywords
- sDTI, Pressure ulcers, Therapy surfaces, Mattresses, Deep Tissue Injury, pressure ulcer treatment
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AFT bedDevice
Also called Clinitron® Rite HiteTM bed
All identified patients will receive a AFT bed for a maximum of 21 days or until discharge
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of breakdown
This case series seeks to identify patients with suspected DTI and capture actual patient outcomes with AFT treatment
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2011 (estimated)
- Study startAug 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hill-Rom
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292980
- Sponsor's protocol ID
- CR-2009-08
- Status last verified
- Feb 2011
- First submitted
- 8 Feb 2011
- Last updated
- 11 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Air Fluidized Therapy Use in Patients Who Present With Suspected Deep Tissue Injury - a Case Series
- ClinicalTrials.gov ID
- NCT01292980
- Acronym / sponsor ID
- CR-2009-08
- Conditions
- Pressure Ulcers
- Keywords
- sDTI, Pressure ulcers, Therapy surfaces, Mattresses, Deep Tissue Injury, pressure ulcer treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Hill-RomIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 10 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who present to the hospital with SDTI
Key inclusion criteria (7 listed)
- Patients with sDTI on the supine aspect of their body
- Patient does not require a pulmonary specialty bed for care
- Patient is expected to be in the hospital for at least 3 days
- Patient weighs between 30 and 350 Lbs.
- Patient's height is less than 75 inches tall
Key exclusion criteria (2 listed)
- Patient is less than 18 years of age
- Patient has already participated in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AFT bedAlso: Clinitron® Rite HiteTM bedAll identified patients will receive a AFT bed for a maximum of 21 days or until discharge | Device | – |
Primary outcome
Degree of breakdown
Time frame: 21 days
This case series seeks to identify patients with suspected DTI and capture actual patient outcomes with AFT treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pressure Ulcers, run by Hill-Rom at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of breakdown (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2011.