Clinical trial NCT03114345: Correlation Between Pressure Differences and Micro-vascularization Changes in Bedridden Paraplegic Patient
Official title: Correlation Between Pressure Differences and Micro-vascularization Changes in Bedridden Paraplegic Patient
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pressure Ulcer
Bedsore
Spinal Cord Injury
Paraplegia
Keywords: Pressure ulcer
Interface pressure
Pressure mapping device
Monitoring
Microvascularization
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Hill-Rom
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2017-04-14
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Measure of the pressure intensity in one area
timeFrame: Measurements are done the same date as the inclusion, during the patient hospitalization for his/her pressure ulcer related surgery.
measure: Measure of the hemoglobin quantity in the same area
timeFrame: Measurements are done the same date as the inclusion, during the patient hospitalization for his/her pressure ulcer related surgery.
Secondary outcomes:
measure: Measure of other micro-vascularization related parameters (such as the oxygen saturation and the blood flow) recorded at the same area.
timeFrame: Measurements are done the same date as the inclusion, during the patient hospitalization for his/her pressure ulcer related surgery.
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Regional Hospital Lapeyronie
state: Languedoc-Roussillon
Study officials:
affiliation: CHU de Montpellier
name: Stefan Matecki, M.D.
role: PRINCIPAL_INVESTIGATOR
References: