Pressure UlcersNCT00405834
A Pilot Study of the Envision® Surface
An observational study of Pressure Ulcers, run by Hill-Rom at 1 site in United States.
Trial summary
This study is to evaluate the clinical safety and effectiveness of the Envision® surface. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pressure Ulcers
- What is being tested?
- Envision® Patient Support System
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Oct 2007
- 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
Who may be able to join
- Subject weighs between 70 and 400 pounds Subject to remain on Envision Surface for at least 3 days Subject at risk for pressure ulcers (Braden Score < 14) or has existing ulcer of any stage Subject is able to provide voluntary consent
Who cannot join
- Subject requires pulmonary treatment surface Subject declines consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
About this study
Official title: A Pilot Study of the Envision® Surface in a Patient Population at High Risk for or Who Have Pressure Ulcers: Evaluation of Pressure Ulcer Incidence, Changes in Existing Pressure Ulcers, Clinical Staff Satisfaction and Patient Comfort
This study is to evaluate the clinical safety and effectiveness of the Envision® surface.
Read the detailed description
This study is to evaluate the clinical safety and effectiveness of the Envision® surface placed on the TotalCare® frame in pressure ulcer prevention and management, patient comfort, and staff acceptance in the critical care environment
- Conditions
- Pressure Ulcers
- Being tested
- Envision® Patient Support System
- Keywords
- Pressure Ulcers
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Envision® Patient Support SystemDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2006 (estimated)
- Study startJun 2007
- Study completionOct 2007
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
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hill-Rom
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Betsy Fisher, RN, CWOCN, Study director, Sinai Hospital of Baltimore / Lifebridge Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00405834
- Sponsor's protocol ID
- CR-0065
- Status last verified
- Jun 2007
- First submitted
- 28 Nov 2006
- Last updated
- 4 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Envision® Surface in a Patient Population at High Risk for or Who Have Pressure Ulcers: Evaluation of Pressure Ulcer Incidence, Changes in Existing Pressure Ulcers, Clinical Staff Satisfaction and Patient Comfort
- ClinicalTrials.gov ID
- NCT00405834
- Acronym / sponsor ID
- CR-0065
- Conditions
- Pressure Ulcers
- Keywords
- Pressure Ulcers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hill-RomIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Study completion
- Oct 2007 (actual)
- First posted
- 30 Nov 2006 (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.
This study is to evaluate the clinical safety and effectiveness of the Envision® surface.
Detailed description
This study is to evaluate the clinical safety and effectiveness of the Envision® surface placed on the TotalCare® frame in pressure ulcer prevention and management, patient comfort, and staff acceptance in the critical care environment
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Subject weighs between 70 and 400 pounds Subject to remain on Envision Surface for at least 3 days Subject at risk for pressure ulcers (Braden Score < 14) or has existing ulcer of any stage Subject is able to provide voluntary consent
Key exclusion criteria (1 listed)
- Subject requires pulmonary treatment surface Subject declines consent
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 |
|---|---|---|
| Envision® Patient Support System | Device | – |
Primary outcome
Not reported in the source record.
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 4 Jul 2008.
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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.
Betsy Fisher, RN, CWOCN study director
Sinai Hospital of Baltimore / Lifebridge Health
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 1 inclusion and 1 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 4 Jul 2008. 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.
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 4 Jul 2008.