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Preliminary Study Leading to Prevention of Pressure Ulcers by the Use of an On-board Device : Ergonomic Assessment of Wheelchair-seat Pressures in Spinal Cord Injured (SCI) Patients ( PRESDIE) (PRESDIE)

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ClinicalTrials.gov Identifier: NCT01834417
Recruitment Status : Active, not recruiting
First Posted : April 17, 2013
Last Update Posted : December 4, 2017
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief Summary:
Analysis of stored seat-pressures in SCI patients during a 4-week use of an on-board device. During this period, patients write in an agenda noteworthy events that could occur while they're using their wheelchair. A control is done every week and the device can be changed until it is returned at the end of the study period.

Condition or disease Intervention/treatment Phase
Pressure Ulcer Device: TexiMat Not Applicable

Detailed Description:
  • inclusion visit : recovery of the signed informed-consent form, clinical examination, skin control, seat-pressures control, device 9-position control, delivery of the agenda for noteworthy events
  • 3 follow-up visits : noteworthy events check, skin control, cushioncloth control, device 9-position control
  • return visit : device return, agenda return, skin control, seat-pressures control

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Preliminary Study Leading to Prevention of Pressure Ulcers by the Use of an On-board Device : Ergonomic Assessment of Wheelchair-seat Pressures in Spinal Cord Injured (SCI) Patients
Actual Study Start Date : April 18, 2013
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores
U.S. FDA Resources




Primary Outcome Measures :
  1. Intra- and inter-patients variability of stored pressures for the whole included population Intra- and inter-patients variability of stored pressures for the whole included population [ Time Frame: 4 weeks ]

    Intra- and inter-patients variability of stored pressures for the whole included population Measured at the end of the study

    Each topic will be equipped with a layer of pressure sensors 32x32. The pressure maps are stored every second rule, which will be of the order of 30 000 maps daily. For each topic, we will be able to calculate the frequency and location of peak pressure



Secondary Outcome Measures :
  1. Intra- and inter-patients variability of stored pressures for subpopulations [ Time Frame: 4 weeks ]

    Intra- and inter-patients variability of stored pressures for subpopulations :

    • quadriplegic vs paraplegic
    • according to high-risk areas for pressure ulcers
    • according to noteworthy events

    Each topic will be equipped with a layer of pressure sensors 32x32. The pressure maps are stored every second rule, which will be of the order of 30 000 maps daily. For each topic, we will be able to calculate the frequency and location of peak pressure Measured at the end of the study




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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • Patient is male or female, aged ≥ 18
  • Patient accepting the initial assessment and the following visits during the protocol
  • Written informed consent has been obtained
  • Patient having a social assurance
  • Spinal cord injury ≤ C6 stable Spinal cord trauma > 1 an
  • Main mode of ambulation : own manual wheelchair

Exclusion criteria :

  • Aged ≤ 18
  • Adults under guardianship
  • Patients do not speak French, refusing or unable to be followed
  • Pregnant or lactating women
  • Person deprived of their liberty by judicial or administrative decision
  • Person hospitalised without consent
  • Pelvic pressure ulcer ongoing
  • Cognitive disorder incompatible with the use of the device, understanding and conduct of the study

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): NCT01834417


Locations
France
CHU Nantes
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Brigitte PERROUIN-VERBE, PU-PH CHU de Nantes- Hôpital Saint Jacques
Study Chair: Marc Le Fort, PH CHU de Nantes-Hôpital Saint Jacques
Study Chair: Guy Egon Centre de l'Arche
Study Chair: Djamel Bensmail, PU-PH CH Raymond Poincaré

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01834417     History of Changes
Other Study ID Numbers: RC11_0009
First Posted: April 17, 2013    Key Record Dates
Last Update Posted: December 4, 2017
Last Verified: November 2017

Keywords provided by Nantes University Hospital:
Pressure ulcer, spinal cord injury, on-board device

Additional relevant MeSH terms:
Ulcer
Pressure Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases