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

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ClinicalTrials.gov Identifier: NCT02412046
Recruitment Status : Recruiting
First Posted : April 8, 2015
Last Update Posted : November 29, 2018
Sponsor:
Collaborator:
Hill-Rom
Information provided by (Responsible Party):
University Hospital, Montpellier

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.


Condition or disease Intervention/treatment Phase
Pressure Ulcer Bedsore Spinal Cord Injury Paraplegia Procedure: Muscle biopsy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Quantification of the Pressure Threshold Related to Tissue Injury in Bedriden Paraplegics
Actual Study Start Date : October 1, 2015
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Active Comparator: Time of the first biopsy: H0
For the patients in arm H0, the first biopsy is done as soon as the patient is lying on the air mattress.
Procedure: Muscle biopsy
Active Comparator: Time of the first biopsy: H1
For a patient in arm H1, it is done after 1 hour lying on the air mattress.
Procedure: Muscle biopsy
Active Comparator: Time of the first biopsy: H2
For a patient in arm H2, it is done after 2 hour lying on the air mattress.
Procedure: Muscle biopsy
Active Comparator: Time of the first biopsy: H3
For a patient in arm H3, it is done after 3 hour lying on the air mattress.
Procedure: Muscle biopsy



Primary Outcome Measures :
  1. The interface pressure will be continuously assessed using a mapping device (XSensor) during 3 hours. [ Time Frame: The first day of the patient admission (during the first 3 hours). ]

Secondary Outcome Measures :
  1. The microvascularization changes underneath the compressed skin and the inflammatory response of the muscle cells. [ Time Frame: The first day of the patient admission (during the first 3 hours). ]
    The blood flow, the oxygen saturation and the hemoglobin amount will be measured using a medical device called Oxygen To See (O2C). The reactive oxygen species or ROS and other specific biomarkers will be used to measure and quantify the inflammatory response of muscle cells.



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Ages Eligible for Study:   18 Years to 90 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,
  • 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)

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): NCT02412046


Contacts
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Contact: STEFAN MATECKI, MD +33 467 415 222 s-matecki@chu-montpellier.fr
Contact: LUC TEOT, MD

Locations
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France
CHU Montpellier Recruiting
Montpellier, France, 34295
Contact: Stephan SM MATECKI, MD    +33 467 415 222    s-matecki@chu-montpellier.fr   
Contact: Marion LEGALL, PhD Student    +33 637 687 230    marion.le-gall@inserm.fr   
Sponsors and Collaborators
University Hospital, Montpellier
Hill-Rom

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02412046    
Other Study ID Numbers: 95022
First Posted: April 8, 2015    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: August 2018
Keywords provided by University Hospital, Montpellier:
Pressure ulcer
Interface pressure
Pressure mapping device
Ischemia reperfusion
Monitoring
Microvascularization
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Paraplegia
Pressure Ulcer
Wounds and Injuries
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Skin Ulcer
Skin Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms