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

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Brief Title

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

Official Title

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

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.
    



Study Type

Interventional


Primary Outcome

Measure of the pressure intensity in one area

Secondary Outcome

 Measure of other micro-vascularization related parameters (such as the oxygen saturation and the blood flow) recorded at the same area.

Condition

Pressure Ulcer

Intervention

Measurement of interface pressure

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

4

Start Date

November 22, 2017

Completion Date

March 5, 2018

Primary Completion Date

March 5, 2018

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.
      

Gender

All

Ages

18 Years - 100 Years

Accepts Healthy Volunteers

No

Contacts

Stefan Matecki, M.D., , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT03114345

Organization ID

9830


Responsible Party

Sponsor

Study Sponsor

University Hospital, Montpellier

Collaborators

 Hill-Rom

Study Sponsor

Stefan Matecki, M.D., Principal Investigator, CHU de Montpellier


Verification Date

April 2020