An interventional study of Muscle biopsy in Pressure Ulcer, Bedsore and Spinal Cord Injury, sponsored by University Hospital, Montpellier. Terminated at 1 site in France. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-12-23.
Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Prevention
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.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's enrollment of 21 is below the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.
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Exclusion Criteria:
For the patients in arm H0, the first biopsy is done as soon as the patient is lying on the air mattress.
Procedure: Muscle biopsy
For a patient in arm H1, it is done after 1 hour lying on the air mattress.
Procedure: Muscle biopsy
For a patient in arm H2, it is done after 2 hour lying on the air mattress.
Procedure: Muscle biopsy
For a patient in arm H3, it is done after 3 hour lying on the air mattress.
Procedure: Muscle biopsy
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).
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.
Time frame: The first day of the patient admission (during the first 3 hours).
This study is terminated, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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University Hospital, Montpellier