Observational Study of the Incidence of Pressure Ulcers o... | NCT02901470

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

NCT02901470

Sponsor

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Last Update Posted

Jan 14, 2019Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Pressure Ulcer

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 11, 2015Actual

Primary Completion Date

Oct 31, 2017Actual

Completion Date

Oct 31, 2017Actual

First Submitted Date

Sep 12, 2016

First Submission Date that Met QC Criteria

Sep 12, 2016

First Posted Date

Sep 15, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2019

Last Update Posted Date

Jan 14, 2019Actual

Description Module

Brief 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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Measure	Description	Time Frame
Incidence of sores in ischiatic zone		30 days

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

98 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
CHU Nîmes		Nîmes	GARD	30000	France

Condition Browse Module

MeSH Terms

ID	Term
D003668	Pressure Ulcer

Ancestor Terms

ID	Term
D012883	Skin Ulcer
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided