Quantification of the Pressure Threshold Related to Tissue Injury in Bedriden Paraplegics

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Brief Title

Quantification of the Pressure Threshold Related to Tissue Injury in Bedriden Paraplegics

Official Title

Quantification of the Pressure Threshold Related to Tissue Injury in Bedriden Paraplegics

Brief Summary

      The aim of this study is to correlate the intensity and the duration of a mechanical strain,
      applied over the skin of a bedridden paraplegics, with the microvascularization parameters
      (oxygen saturation, blood flow and blood volume) and the early inflammatory mechanism. We
      want to detect the early stage of irreversible damage for each patient. To achieve this goal,
      we measure some specifics data over a group of 48 paraplegics admitted in the hospital for a
      pressure ulcer surgical treatment. The patients are randomly distributed in 4 groups. First
      the interface pressure between the patient body and the air mattress is recorded continuously
      for 3 hours (= the repositioning patient frequency): we have the pressure over each point of
      the patient body in contact with the mattress on this time lap. Then, we will measure the
      microvascularization parameters, using an O2C medical device over a trochanter on a specific
      anatomical area which will be thereafter biopsied. Finally, depending on the group in which
      they were randomly distributed, the patient will undergo a muscle biopsy on his or her
      trochanter at 0h, 1h, 2h or 3h after they lie down on the air mattress. This way, we will be
      able to determine the effect of the mechanical strain duration on the physiologic parameters.
      The following day, the patient is undergoing his or her surgery for removing the necrotic
      area of the bedsore. At the same time, we will recover some of the sample near the bedsore
      which would serve as a maximum inflammatory response. Then a second muscle biopsy will be
      performed on an innervated area to be able to determine a basal concentration of biomarkers.

      The inclusion period for this study will be 3 years. All the patients are followed for 24
      hours then they will be followed by medical staff in their bedsore resection setting.

      The data gained for this study will hopefully help the scientific world to achieve a better
      understanding of the pressure ulcer aetiology. They will also be helpful to achieve a
      mobilization of the patient specific of his or her inherent characteristics with a high
      sensitivity level. This way we will have a more efficient bedsore prevention.
    



Study Type

Interventional


Primary Outcome

The interface pressure will be continuously assessed using a mapping device (XSensor) during 3 hours.

Secondary Outcome

 The microvascularization changes underneath the compressed skin and the inflammatory response of the muscle cells.

Condition

Pressure Ulcer

Intervention

Muscle biopsy

Study Arms / Comparison Groups

 Time of the first biopsy: H0
Description:  For the patients in arm H0, the first biopsy is done as soon as the patient is lying on the air mattress.

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

Procedure

Estimated Enrollment

21

Start Date

October 1, 2015

Completion Date

March 28, 2018

Primary Completion Date

March 27, 2018

Eligibility Criteria

        Inclusion Criteria:

          -  Educated consent signed,

          -  Older than 18,

          -  Paraplegia for at least 6 months,

          -  Patient's Body Mass Index > 18,5kg/m²,

          -  Surgery planned for pressure ulcer resection,

          -  Pressure Ulcer classification (EPUAP) at least III or IV

        Exclusion Criteria:

          -  Cardiac pathology,

          -  Duchenne muscular dystrophy,

          -  Dementia,

          -  Presence of a tumourous wound,

          -  Stade IV arteritis non-revascularisable,

          -  Diabetes mellitus,

          -  Cachexia,

          -  Impossibility to stop the anti-coagulant treatment 24 hours before the patient
             admission,

          -  Xylocaine allergy,

          -  Patient took aspirin or anti-inflammatory 3 days before the biopsy,

          -  Patient taking part in another study,

          -  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)
      

Gender

All

Ages

18 Years - 90 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT02412046

Organization ID

95022


Responsible Party

Sponsor

Study Sponsor

University Hospital, Montpellier

Collaborators

 Hill-Rom

Study Sponsor

, , 


Verification Date

April 2020