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

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.

Study Overview

• Status: Terminated
• Conditions: Spinal Cord Injury; Pressure Ulcer; Paraplegia; Bedsore
• Intervention / Treatment: Other: Measurement of interface pressure; Other: Measurement of micro-vascularization related parameters

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Languedoc-Roussillon
    • Montpellier, Languedoc-Roussillon, France, 34295
      • University Regional Hospital Lapeyronie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

OTHER: Single arm; Measurement of interface pressure and Measurement of micro-vascularization related parameters

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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; Hill-Rom
• Investigators: Principal Investigator: Stefan Matecki, M.D., CHU de Montpellier

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 22, 2017
• Primary Completion (ACTUAL): November 22, 2019
• Study Completion (ACTUAL): November 22, 2019

Study Registration Dates

• First Submitted: March 30, 2017
• First Submitted That Met QC Criteria: April 10, 2017
• First Posted (ACTUAL): April 14, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 9, 2021
• Last Update Submitted That Met QC Criteria: December 8, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Monitoring; Pressure ulcer; Interface pressure; Pressure mapping device; Microvascularization
• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Skin Diseases; Neurologic Manifestations; Wounds and Injuries; Skin Ulcer; Trauma, Nervous System; Spinal Cord Diseases; Metaplasia; Paralysis; Neovascularization, Pathologic; Spinal Cord Injuries; Pressure Ulcer; Paraplegia
• Other Study ID Numbers: 9830

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No