NCT02901470

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 11, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2017

Completed
Last Updated

January 14, 2019

Status Verified

January 1, 2019

Enrollment Period

2.7 years

First QC Date

September 12, 2016

Last Update Submit

January 11, 2019

Conditions

Pressure Ulcer

Outcome Measures

Primary Outcomes (1)

  • Incidence of sores in ischiatic zone

    30 days

Eligibility Criteria

Age20 Years - 98 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Nîmes

Nîmes, GARD, 30000, France

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2016

First Posted

September 15, 2016

Study Start

February 11, 2015

Primary Completion

October 31, 2017

Study Completion

October 31, 2017

Last Updated

January 14, 2019

Record last verified: 2019-01

Locations

FR(1)