Observational Study of the Incidence of Pressure Ulcers on the Help Support of Prevention of Bedsores POLYAIR®

January 11, 2019 updated by: Centre Hospitalier Universitaire de Nīmes
The support of help to the prevention of sores include a big diversity of devices. The clinical experiment of these support comes up against the problem of the large number of factors participants in the genesis of bedsores. Nevertheless, it seems to be interesting to estimate the incidence of bedsores in these supports, with control of other factors

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Gard
      • Nîmes, Gard, France, 30000
        • CHU Nîmes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 98 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Persons who are hospitalized in CHU of Nîmes with high risk of sores (Norton <9)

Description

Inclusion Criteria:

  • Norton Index <9,
  • No sores in ischiatic zone,
  • Sitting position not less than 2 hours per day

Exclusion Criteria:

  • Sores in ischiatic zone,
  • Sitting position >2 hours per day

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of sores in ischiatic zone
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2015

Primary Completion (Actual)

October 31, 2017

Study Completion (Actual)

October 31, 2017

Study Registration Dates

First Submitted

September 12, 2016

First Submitted That Met QC Criteria

September 12, 2016

First Posted (Estimate)

September 15, 2016

Study Record Updates

Last Update Posted (Actual)

January 14, 2019

Last Update Submitted That Met QC Criteria

January 11, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Local/2015/EV-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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