UlcersNCT01439581
Utility of Interface Pressure Mapping
A study testing Mapping System and Non-Mapping System in people with Ulcers and Bedsores, run by Henry Ford Health System at 1 site in United States.
Trial summary
To determine if a device that measures and displays pressure that the patients feel when in bed can help nurses reposition the patient effectively and thereby reduce bedsores in the intensive care unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Mapping System and Non-Mapping System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 428 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Sep 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older,
- care giver trained on mapping system
Who cannot join
- Less than 18 years,
- pregnant women,
- weight greater 550 lbs, and subjects requiring a specialty mattress
Trial locations and contacts
1 site in 1 country.
About this study
To determine if a device that measures and displays pressure that the patients feel when in bed can help nurses reposition the patient effectively and thereby reduce bedsores in the intensive care unit.
- Being tested
- Mapping System, Non-Mapping System
- Keywords
- patients, susceptible to, hospital, acquired pressure
- Medical subject headings
- Ulcer, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mapping SystemDevice
Pressure Sensing coverlet on ICU bed and provides real time feedback to assist in effective patient repositioning
Non-Mapping SystemDevice
Standard ICU bed with no mapping system
| Study group | Role | What they receive |
|---|---|---|
| Patients on mapping systems | Experimental | Not described Receives: Device: Mapping System |
| Patients not on mapping systems | Active comparator | Not described Receives: Device: Non-Mapping System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure Mapping Reducing Hospital Acquired Pressure Ulcers
Comparing number of pressure ulcers when using pressure mapping compared to when not.
Measured: Time admitted in the Medical Intensive Care Unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionOct 2011
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were assigned randomly to either a medical intensive care unit with pressure mapping beds or a unit that did not have them
- Masking
- None (open label)
- Enrolment
- 428 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Wellsense USA Inc.
- Responsible party
- Principal investigator, Rob Behrendt, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01439581
- Sponsor's protocol ID
- Interface Pressure Mapping
- Status last verified
- Sep 2019
- First submitted
- 22 Sep 2011
- Last updated
- 12 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Interface Pressure Mapping
- ClinicalTrials.gov ID
- NCT01439581
- Acronym / sponsor ID
- Interface Pressure Mapping
- Keywords
- patients, susceptible to, hospital, acquired pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 428 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- Wellsense USA Inc.
- Study start
- Aug 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 23 Sep 2011 (estimated)
- Results
- Posted 29 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if a device that measures and displays pressure that the patients feel when in bed can help nurses reposition the patient effectively and thereby reduce bedsores in the intensive care unit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients were assigned randomly to either a medical intensive care unit with pressure mapping beds or a unit that did not have them
| Arm | Type | Receives |
|---|---|---|
| Patients on mapping systems | Experimental | Device: Mapping System |
| Patients not on mapping systems | Active comparator | Device: Non-Mapping System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years and older,
- care giver trained on mapping system
Key exclusion criteria (3 listed)
- Less than 18 years,
- pregnant women,
- weight greater 550 lbs, and subjects requiring a specialty mattress
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 |
|---|---|---|
| Mapping SystemPressure Sensing coverlet on ICU bed and provides real time feedback to assist in effective patient repositioning | Device | Patients on mapping systems |
| Non-Mapping SystemStandard ICU bed with no mapping system | Device | Patients not on mapping systems |
Primary outcome
Pressure Mapping Reducing Hospital Acquired Pressure Ulcers
Time frame: Time admitted in the Medical Intensive Care Unit
Comparing number of pressure ulcers when using pressure mapping compared to when not.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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?
A study testing Mapping System and Non-Mapping System in people with Ulcers and Bedsores, run by Henry Ford Health System 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 2 inclusion and 3 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 12 Sep 2019. 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?
Yes. Results are posted in the registry (first posted 29 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pressure Mapping Reducing Hospital Acquired Pressure Ulcers (time frame: Time admitted in the Medical Intensive Care Unit). 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 12 Sep 2019.