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

NCT ID: NCT03114345

Last Updated: 2021-12-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-22
• Study Completion Date: 2019-11-22

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Single arm

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

Group Type: OTHER

Measurement of interface pressure

Intervention Type: 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.

Measurement of micro-vascularization related parameters

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hill-Rom

INDUSTRY

Sponsor Role: collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stefan Matecki, M.D.

Role: PRINCIPAL_INVESTIGATOR

CHU de Montpellier

Locations

University Regional Hospital Lapeyronie

Montpellier, Languedoc-Roussillon, France

Countries

France

Other Identifiers

9830

Identifier Type: -

Identifier Source: org_study_id