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)

This study is not yet open for participant recruitment.
Verified April 2013 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01834417
First received: April 8, 2013
Last updated: April 15, 2013
Last verified: April 2013
  Purpose

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 Intervention
- Pressure Ulcers
Device: TexiMat

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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:
  • 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



Estimated Enrollment: 90
Study Start Date: April 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01834417

Contacts
Contact: Brigitte PERROUIN-VERBE brigitte.perrouinverbe@chu-nantes.fr

Locations
France
CHU Nantes Not yet recruiting
Nantes, France, 44093
Principal Investigator: PERROUIN-VERBE BRIGITTE         
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
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01834417     History of Changes
Other Study ID Numbers: 11_0009
Study First Received: April 8, 2013
Last Updated: April 15, 2013
Health Authority: FRANCE : ANSM

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

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

ClinicalTrials.gov processed this record on April 20, 2014