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

Not Applicable

Terminated

• Conditions: Pressure Ulcer; Bedsore; Paraplegia; Spinal Cord Injury
• Interventions: Other: Measurement of interface pressure; Other: Measurement of micro-vascularization related parameters

• Registration Number: NCT03114345
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-30
• Study First Submitted QC: 2017-04-10
• Study First Posted: 2017-04-14
• Study Start: 2017-11-22
• Primary Completion: 2019-11-22
• Study Completion: 2019-11-22
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-08
• Last Update Posted: 2021-12-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	Measurement of interface pressure	Measurement of interface pressure and Measurement of micro-vascularization related parameters
Single arm	Measurement of micro-vascularization related parameters	Measurement of interface pressure and Measurement of micro-vascularization related parameters

Primary Outcome Measures

Name	Time	Method
Measure of the hemoglobin quantity in the same area	Measurements are done the same date as the inclusion, during the patient hospitalization for his/her pressure ulcer related surgery.	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.
Measure of the pressure intensity in one area	Measurements are done the same date as the inclusion, during the patient hospitalization for his/her pressure ulcer related surgery.	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.

Secondary Outcome Measures

Name	Time	Method
Measure of other micro-vascularization related parameters (such as the oxygen saturation and the blood flow) recorded at the same area.	Measurements are done the same date as the inclusion, during the patient hospitalization for his/her pressure ulcer related surgery.	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.

Trial Locations

Locations (1)

University Regional Hospital Lapeyronie; 🇫🇷 Montpellier, Languedoc-Roussillon, France