Correlation Between Pressure Differences and Micro-vascularization Changes in Bedridden Paraplegic Patient

Study Overview
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Brief Summary
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Paraplegic patients have defective wound healing for sore below the level of spinal lesion. Defect of vascularization of the healing zone certainly participate to this effect. Therefore, this study want to measure, in a clinical settings, the interface pressure (e.g. the pressure between the patient body and the surface he/she is lying on) to assess the correlation between mechanical stress in term of pressure applied over time and tissue oxygenation which represent micro-vascular function. The aim of this clinical trial is to correlate the variations of pressure intensities and changes in micro-vascularization. The measure are recorded when paraplegic patient came into the hospital for pressure ulcer related surgery. The patient is laying on his/her mattress on top of a flexible pressure mapping device. The micro-vascularization parameters are measured at the area displaying the peak pressure a few minutes after the beginning of the pressure interface recording and one hour later at the same area. The data generated during this monocentric study will help to achieve a better understanding of the relation between pressure and micro-vascularization. In the mid term, it will provide a better and more patient adapted pressure ulcer prevention.

Official Title
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Correlation Between Pressure Differences and Micro-vascularization Changes in Bedridden Paraplegic Patient

Conditions
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Pressure Ulcer, Bedsore, Spinal Cord Injury, Paraplegia

Intervention / Treatment
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* Other: Measurement of interface pressure
* Other: Measurement of micro-vascularization related parameters


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Educated consent signed, Older than 18, Paraplegia for at least 6 months, Surgery planned for pressure ulcer resection, Exclusion Criteria: Dementia, Stade IV arteritis non-revascularisable, 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), Patient taking part in another study which could impact the local micro-vascularization.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single arm<br>Measurement of interface pressure and Measurement of micro-vascularization related parameters | Other: Measurement of interface pressure<br>* A capacitive pressure mapping device (XSensor) is set up on the patient air mattress bed. It records the interface pressure on the whole patient body with one frame every second during one hour. Then the file is saved and the pressure mapping device is removed from the patient hospital bedroom.<br>Other: Measurement of micro-vascularization related parameters<br>* A medical device called O2C, measuring micro-vascularization related parameters (oxygen saturation, hemoglobin quantity and blood flow) is used. The probe (= an optic fibre) is set up lightly on the patient skin or on a transparent adhesive for 1 minute. The median value of the local micro-vascularization parameters are saved on the O2C interface. The location of the measurement is chosen using the pressure mapping device to locate peak pressure area. Then the O2C is removed from the patient hospital bedroom.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of the pressure intensity in one area | Pressure intensity is recorded using a mapping pressure device (XSensor), set up on the patient hospital bed. Hemoglobin quantity is measured the same day, at a precise area identified on the pressure mapping device (peak pressure), using the O2C - a micro-vascularization device. All measure are non-invasive. | Measurements are done the same date as the inclusion, during the patient hospitalization for his/her pressure ulcer related surgery. | 
| Measure of the hemoglobin quantity in the same area | Hemoglobin quantity is measured the same day, at a precise area identified on the pressure mapping device (peak pressure), using the O2C - a micro-vascularization device. All measure are non-invasive. | Measurements are done the same date as the inclusion, during the patient hospitalization for his/her pressure ulcer related surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of other micro-vascularization related parameters (such as the oxygen saturation and the blood flow) recorded at the same area. | All micro-vascularization related parameters are measured the same day, at a precise area identified on the pressure mapping device (peak pressure), using the O2C - a micro-vascularization device. All measure are non-invasive. | Measurements are done the same date as the inclusion, during the patient hospitalization for his/her pressure ulcer related surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pressure ulcer, Interface pressure, Pressure mapping device, Monitoring, Microvascularization