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Trial record 13 of 28 for:    Recruiting, Not yet recruiting, Available Studies | "Paraplegia"

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

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ClinicalTrials.gov Identifier: NCT03114345
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : May 22, 2018
Sponsor:
Collaborators:
Hill-Rom
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pressure Ulcer Bedsore Spinal Cord Injury Paraplegia Other: Measurement of interface pressure Other: Measurement of micro-vascularization related parameters Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Correlation Between Pressure Differences and Micro-vascularization Changes in Bedridden Paraplegic Patient
Actual Study Start Date : November 22, 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Measure of the pressure intensity in one area [ Time Frame: 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.

  2. Measure of the hemoglobin quantity in the same area [ Time Frame: 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.


Secondary Outcome Measures :
  1. Measure of other micro-vascularization related parameters (such as the oxygen saturation and the blood flow) recorded at the same area. [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03114345


Contacts
Contact: Stefan Matecki, M.D. +33 467 415 222 s-matecki@chu-montpellier.fr

Locations
France
University Regional Hospital Lapeyronie Recruiting
Montpellier, Languedoc-Roussillon, France, 34295
Contact: Stefan Matecki, M.D.    +33 467 415 222    s-matecki@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
Hill-Rom
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Stefan Matecki, M.D. CHU de Montpellier

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03114345     History of Changes
Other Study ID Numbers: 9830
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Montpellier:
Pressure ulcer
Interface pressure
Pressure mapping device
Monitoring
Microvascularization

Additional relevant MeSH terms:
Paraplegia
Spinal Cord Injuries
Pressure Ulcer
Neovascularization, Pathologic
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Skin Ulcer
Skin Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms
Metaplasia
Pathologic Processes