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NCT02901470 Clinical Trial

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

Pressure Ulcer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02901470
Other study ID # Local/2015/EV-02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 11, 2015
Est. completion date October 31, 2017

Study information
Verified date January 2019
Source Centre Hospitalier Universitaire de Nimes
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date October 31, 2017
Est. primary completion date October 31, 2017
Accepts healthy volunteers No
Gender All
Age group 20 Years to 98 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
France CHU Nîmes Nîmes Gard

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of sores in ischiatic zone 30 days
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