Pressure Ulcer Stage 1BEDSORESNCT02173431
Recognize High Pressure Areas in Human Body to Prevent Decubitus Ulcers
An observational study of Pressure Ulcer Stage 1, run by Assuta Medical Center at 1 site in Israel.
Trial summary
Prolonged external pressure to the tissue leads to compression, ischemia and development of pressure ulcer. Underweight seems to be associated with high pressure ulcer risk but the distinct relation between overweight and pressure ulcer development is uncertain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcer Stage 1
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2014to Dec 2014
- How long will I take part?
- 30 Days
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from 18 y.o. before elective operation will be recruited for the study/ Any patient will be enroled in each group' seven in total according the BMI.
Who may be able to join
- Any patient admitted for elective surgery,
- Patients above 18 y.o.,
- Patient admitted for surgery that required 3 or more days in hospital
Who cannot join
- Patients under 18
- Patients that require emergency surgery
- Patients that have bedsores before admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mapping Pressure of Human Body to Prevent Bedsores
Prolonged external pressure to the tissue leads to compression, ischemia and development of pressure ulcer.
Underweight seems to be associated with high pressure ulcer risk but the distinct relation between overweight and pressure ulcer development is uncertain.
Bedsores are caused by pressure against the skin that limits blood flow to the skin and nearby tissue.
Others factors related to limited mobility can make the skin vulnerable to damage and contribute to the development of pressure sores. Three primary contributing factors are sustained pressure, friction and shear.
Bedsores are easier to prevent than to treat.
Read the detailed description
- age
- weight
- high
- BMI
- pressure scanning map
- Alimentary status
- Diseases
- Conditions
- Pressure Ulcer Stage 1
- Keywords
- BMI, Pressure, Bedsore
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| BMI 20 to 24.99 | 30 patients | |
| BMI 25 to 29.99 | 30 patients | |
| BMI 30 to 34.99 | 30 patients | |
| BMI 35 to 39.99 | 30 patients | |
| BMI 40 to 44.99 | 30 patients | |
| BMI 45 to 49.99 | 30 patients | |
| BMI more than 50 | 30 patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mapping body pressure
The patient need to rest above a mattress with sensors for pressure and the data is obtained by an specific software
Measured: up to 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Why it stopped: due to technical issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure Ulcer Stage 1Studies 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
- 0 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Assuta Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergio Gabriel Susmallian, Assuta Medical Center
- Investigators
- Sergio G Susmallian, M.D., Principal investigator, ASSUTA MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02173431
- Sponsor's protocol ID
- SCO0414
- Other IDs
- relation of pressure in gender
- Acronym
- BEDSORES
- Status last verified
- Mar 2016
- First submitted
- 10 Apr 2014
- Last updated
- 29 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping Pressure of Human Body to Prevent Bedsores
- ClinicalTrials.gov ID
- NCT02173431
- Acronym / sponsor ID
- BEDSORES / SCO0414
- Conditions
- Pressure Ulcer Stage 1
- Keywords
- BMI, Pressure, Bedsore
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: due to technical issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assuta Medical CenterUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 25 Jun 2014 (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.
Prolonged external pressure to the tissue leads to compression, ischemia and development of pressure ulcer.
Underweight seems to be associated with high pressure ulcer risk but the distinct relation between overweight and pressure ulcer development is uncertain.
Bedsores are caused by pressure against the skin that limits blood flow to the skin and nearby tissue.
Others factors related to limited mobility can make the skin vulnerable to damage and contribute to the development of pressure sores. Three primary contributing factors are sustained pressure, friction and shear.
Bedsores are easier to prevent than to treat.
Detailed description
- age
- weight
- high
- BMI
- pressure scanning map
- Alimentary status
- Diseases
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| BMI 20 to 24.99 | – | –30 patients |
| BMI 25 to 29.99 | – | –30 patients |
| BMI 30 to 34.99 | – | –30 patients |
| BMI 35 to 39.99 | – | –30 patients |
| BMI 40 to 44.99 | – | –30 patients |
| BMI 45 to 49.99 | – | –30 patients |
| BMI more than 50 | – | –30 patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from 18 y.o. before elective operation will be recruited for the study/ Any patient will be enroled in each group' seven in total according the BMI.
Key inclusion criteria (3 listed)
- Any patient admitted for elective surgery,
- Patients above 18 y.o.,
- Patient admitted for surgery that required 3 or more days in hospital
Key exclusion criteria (3 listed)
- Patients under 18
- Patients that require emergency surgery
- Patients that have bedsores before admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mapping body pressure
Time frame: up to 6 month
The patient need to rest above a mattress with sensors for pressure and the data is obtained by an specific software
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2016.
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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.
Sergio G Susmallian, M.D. principal investigator
ASSUTA MC
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 Ulcer Stage 1, run by Assuta Medical Center at 1 site in Israel.
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 3 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: withdrawn, as of the sponsor's last update on 29 Mar 2016. 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 Israel. 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 was withdrawn before enrolling participants, so there are no results.
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?
Mapping body pressure (time frame: up to 6 month). 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 29 Mar 2016.