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

University Hospital Center (CHU)

Status: Terminated

Conditions: Pressure Ulcer; Spinal Cord Injury; Bedsore; Paraplegia

Treatments: Other: Measurement of interface pressure; Other: Measurement of micro-vascularization related parameters

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03114345

9830

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Single arm

Other group

Description:

Measurement of interface pressure and Measurement of micro-vascularization related parameters

Treatment:

Other: Measurement of micro-vascularization related parameters

Other: Measurement of interface pressure