NCT03114345

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pressure Ulcer
• Bedsore
• Spinal Cord Injury
• Paraplegia

Interventions

Type	Name	Description
OTHER	Measurement of interface pressure	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.
OTHER	Measurement of micro-vascularization related parameters	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.

Timeline

• Start date: 2017-11-22
• Primary completion: 2019-11-22
• Completion: 2019-11-22
• First posted: 2017-04-14
• Last updated: 2021-12-09

Locations

1 site across 1 country: France