Pressure UlcerNCT02412046
Quantification of the Pressure Threshold Related to Tissue Injury in Bedriden Paraplegics
A study testing Muscle biopsy in people with Pressure Ulcer and Bedsore, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The aim of this study is to correlate the intensity and the duration of a mechanical strain, applied over the skin of a bedridden paraplegics, with the microvascularization parameters (oxygen saturation, blood flow and blood volume) and the early inflammatory mechanism. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pressure Ulcer, Bedsore, Spinal Cord Injury
- What is being tested?
- Muscle biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2015to 2 Oct 2019
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Educated consent signed,
- Older than 18,
- Paraplegia for at least 6 months,
- Patient's Body Mass Index > 18,5kg/m²,
- Surgery planned for pressure ulcer resection,
- Pressure Ulcer classification (EPUAP) at least III or IV
Who cannot join
- Cardiac pathology,
- Duchenne muscular dystrophy,
- Dementia,
- Presence of a tumourous wound,
- Stade IV arteritis non-revascularisable,
- Diabetes mellitus,
Show all 13Show fewer
- Cachexia,
- Impossibility to stop the anti-coagulant treatment 24 hours before the patient admission,
- Xylocaine allergy,
- Patient took aspirin or anti-inflammatory 3 days before the biopsy,
- Patient taking part in another study,
- Patient with no health insurance,
- Pregnant women or breast-feeding, patient unable to give his or her educated consent, ward of the state (art. L.1121-6, L.1121-7, L.1211-8, L.1211-9)
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to correlate the intensity and the duration of a mechanical strain, applied over the skin of a bedridden paraplegics, with the microvascularization parameters (oxygen saturation, blood flow and blood volume) and the early inflammatory mechanism. We want to detect the early stage of irreversible damage for each patient. To achieve this goal, we measure some specifics data over a group of 48 paraplegics admitted in the hospital for a pressure ulcer surgical treatment. The patients are randomly distributed in 4 groups. First the interface pressure between the patient body and the air mattress is recorded continuously for 3 hours (= the repositioning patient frequency): we have the pressure over each point of the patient body in contact with the mattress on this time lap. Then, we will measure the microvascularization parameters, using an O2C medical device over a trochanter on a specific anatomical area which will be thereafter biopsied. Finally, depending on the group in which they were randomly distributed, the patient will undergo a muscle biopsy on his or her trochanter at 0h, 1h, 2h or 3h after they lie down on the air mattress. This way, we will be able to determine the effect of the mechanical strain duration on the physiologic parameters. The following day, the patient is undergoing his or her surgery for removing the necrotic area of the bedsore. At the same time, we will recover some of the sample near the bedsore which would serve as a maximum inflammatory response. Then a second muscle biopsy will be performed on an innervated area to be able to determine a basal concentration of biomarkers.
The inclusion period for this study will be 3 years. All the patients are followed for 24 hours then they will be followed by medical staff in their bedsore resection setting.
The data gained for this study will hopefully help the scientific world to achieve a better understanding of the pressure ulcer aetiology. They will also be helpful to achieve a mobilization of the patient specific of his or her inherent characteristics with a high sensitivity level. This way we will have a more efficient bedsore prevention.
- Conditions
- Pressure Ulcer, Bedsore, Spinal Cord Injury, Paraplegia
- Being tested
- Muscle biopsy
- Keywords
- Pressure ulcer, Interface pressure, Pressure mapping device, Ischemia reperfusion, Monitoring, Microvascularization
- Medical subject headings
- Pressure Ulcer, Spinal Cord Injuries, Paraplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle biopsyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Time of the first biopsy: H0 | Active comparator | For the patients in arm H0, the first biopsy is done as soon as the patient is lying on the air mattress. Receives: Procedure: Muscle biopsy |
| Time of the first biopsy: H1 | Active comparator | For a patient in arm H1, it is done after 1 hour lying on the air mattress. Receives: Procedure: Muscle biopsy |
| Time of the first biopsy: H2 | Active comparator | For a patient in arm H2, it is done after 2 hour lying on the air mattress. Receives: Procedure: Muscle biopsy |
| Time of the first biopsy: H3 | Active comparator | For a patient in arm H3, it is done after 3 hour lying on the air mattress. Receives: Procedure: Muscle biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The interface pressure will be continuously assessed using a mapping device (XSensor) during 3 hours.
Measured: The first day of the patient admission (during the first 3 hours).
Secondary outcomes (1)
The microvascularization changes underneath the compressed skin and the inflammatory response of the muscle cells.
The blood flow, the oxygen saturation and the hemoglobin amount will be measured using a medical device called Oxygen To See (O2C). The reactive oxygen species or ROS and other specific biomarkers will be used to measure and quantify the inflammatory response of muscle cells.
Measured: The first day of the patient admission (during the first 3 hours).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study start1 Oct 2015
- Primary completion2 Oct 2019
- Study completion2 Oct 2019
Why it stopped: Departure of the PhD in charge of the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Hill-Rom
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02412046
- Sponsor's protocol ID
- 95022
- Status last verified
- Dec 2021
- First submitted
- 3 Apr 2015
- Last updated
- 23 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of the Pressure Threshold Related to Tissue Injury in Bedriden Paraplegics
- ClinicalTrials.gov ID
- NCT02412046
- Acronym / sponsor ID
- 95022
- Conditions
- Pressure Ulcer, Bedsore, Spinal Cord Injury, Paraplegia
- Keywords
- Pressure ulcer, Interface pressure, Pressure mapping device, Ischemia reperfusion, Monitoring, Microvascularization
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Departure of the PhD in charge of the study
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Hill-Rom
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 2 Oct 2019 (actual)
- Study completion
- 2 Oct 2019 (actual)
- First posted
- 8 Apr 2015 (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.
The aim of this study is to correlate the intensity and the duration of a mechanical strain, applied over the skin of a bedridden paraplegics, with the microvascularization parameters (oxygen saturation, blood flow and blood volume) and the early inflammatory mechanism. We want to detect the early stage of irreversible damage for each patient. To achieve this goal, we measure some specifics data over a group of 48 paraplegics admitted in the hospital for a pressure ulcer surgical treatment. The patients are randomly distributed in 4 groups. First the interface pressure between the patient body and the air mattress is recorded continuously for 3 hours (= the repositioning patient frequency): we have the pressure over each point of the patient body in contact with the mattress on this time lap. Then, we will measure the microvascularization parameters, using an O2C medical device over a trochanter on a specific anatomical area which will be thereafter biopsied. Finally, depending on the group in which they were randomly distributed, the patient will undergo a muscle biopsy on his or her trochanter at 0h, 1h, 2h or 3h after they lie down on the air mattress. This way, we will be able to determine the effect of the mechanical strain duration on the physiologic parameters. The following day, the patient is undergoing his or her surgery for removing the necrotic area of the bedsore. At the same time, we will recover some of the sample near the bedsore which would serve as a maximum inflammatory response. Then a second muscle biopsy will be performed on an innervated area to be able to determine a basal concentration of biomarkers.
The inclusion period for this study will be 3 years. All the patients are followed for 24 hours then they will be followed by medical staff in their bedsore resection setting.
The data gained for this study will hopefully help the scientific world to achieve a better understanding of the pressure ulcer aetiology. They will also be helpful to achieve a mobilization of the patient specific of his or her inherent characteristics with a high sensitivity level. This way we will have a more efficient bedsore prevention.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Time of the first biopsy: H0 | Active comparator | Procedure: Muscle biopsyFor the patients in arm H0, the first biopsy is done as soon as the patient is lying on the air mattress. |
| Time of the first biopsy: H1 | Active comparator | Procedure: Muscle biopsyFor a patient in arm H1, it is done after 1 hour lying on the air mattress. |
| Time of the first biopsy: H2 | Active comparator | Procedure: Muscle biopsyFor a patient in arm H2, it is done after 2 hour lying on the air mattress. |
| Time of the first biopsy: H3 | Active comparator | Procedure: Muscle biopsyFor a patient in arm H3, it is done after 3 hour lying on the air mattress. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Educated consent signed,
- Older than 18,
- Paraplegia for at least 6 months,
- Patient's Body Mass Index > 18,5kg/m²,
- Surgery planned for pressure ulcer resection,
Key exclusion criteria (13 listed)
- Cardiac pathology,
- Duchenne muscular dystrophy,
- Dementia,
- Presence of a tumourous wound,
- Stade IV arteritis non-revascularisable,
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 |
|---|---|---|
| Muscle biopsy | Procedure or surgery | Time of the first biopsy: H0, Time of the first biopsy: H1, Time of the first biopsy: H2, Time of the first biopsy: H3 |
Primary outcome
The interface pressure will be continuously assessed using a mapping device (XSensor) during 3 hours.
Time frame: The first day of the patient admission (during the first 3 hours).
1 secondary outcome
The microvascularization changes underneath the compressed skin and the inflammatory response of the muscle cells.
Time frame: The first day of the patient admission (during the first 3 hours).
Results and safety
The study was stopped early (reason given: Departure of the PhD in charge of the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2021.
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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 Muscle biopsy in people with Pressure Ulcer and Bedsore, run by University Hospital, Montpellier at 1 site in France.
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 6 inclusion and 13 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: stopped early, as of the sponsor's last update on 23 Dec 2021. 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 France. 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 stopped early (reason given: Departure of the PhD in charge of the study). Results are not available in the source record.
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?
The interface pressure will be continuously assessed using a mapping device (XSensor) during 3 hours. (time frame: The first day of the patient admission (during the first 3 hours).). 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 23 Dec 2021.