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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02173431
Other study ID # SCO0414
Secondary ID relation of pres
Status Withdrawn
Phase N/A
First received April 10, 2014
Last updated March 28, 2016
Start date June 2014
Est. completion date December 2014

Study information

Verified date March 2016
Source Assuta Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Observational [Patient Registry]

Clinical Trial Summary

Prolonged external pressure to the tissue leads to compression, ischemia and development of pressure ulcer.

Underweight seems to be associated with high pressure ulcer risk but the distinct relation between overweight and pressure ulcer development is uncertain.

Bedsores are caused by pressure against the skin that limits blood flow to the skin and nearby tissue.

Others factors related to limited mobility can make the skin vulnerable to damage and contribute to the development of pressure sores. Three primary contributing factors are sustained pressure, friction and shear.

Bedsores are easier to prevent than to treat.


Description:

- age

- weight

- high

- BMI

- pressure scanning map

- Alimentary status

- Diseases


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Any patient admitted for elective surgery,

- Patients above 18 y.o.,

- Patient admitted for surgery that required 3 or more days in hospital

Exclusion Criteria:

- Patients under 18

- Patients that require emergency surgery

- Patients that have bedsores before admission

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Israel ASSUTAMC Tel Aviv

Sponsors (1)

Lead Sponsor Collaborator
Assuta Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mapping body pressure The patient need to rest above a mattress with sensors for pressure and the data is obtained by an specific software up to 6 month Yes