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

NCT03114345 | Terminated

• 1 other identifier: 9830
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Pressure Ulcer; Bedsore; Spinal Cord Injury; Paraplegia

Keywords

Pressure ulcer; Interface pressure; Pressure mapping device; Monitoring; Microvascularization

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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.

Study Arms (1)

Single arm

OTHER

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

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

Interventions

Measurement of interface pressure OTHER

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.

Single arm

Measurement of micro-vascularization related parameters OTHER

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.

Single arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Educated consent signed,
• Older than 18,
• Paraplegia for at least 6 months,
• Surgery planned for pressure ulcer resection,

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Hill-Rom: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

University Regional Hospital Lapeyronie

Montpellier, Languedoc-Roussillon, 34295, France

Location

MeSH Terms

Conditions

Pressure Ulcer; Spinal Cord Injuries; Paraplegia

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefan Matecki, M.D.

  CHU de Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: April 14, 2017
• Study Start: November 22, 2017
• Primary Completion: November 22, 2019
• Study Completion: November 22, 2019
• Last Updated: December 9, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)