Recognize High Pressure Areas in Human Body to Prevent Decubitus Ulcers (BEDSORES)

March 28, 2016 updated by: Sergio Gabriel Susmallian, Assuta Medical Center

Mapping Pressure of Human Body to Prevent Bedsores

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.

Study Overview

Status

Withdrawn

Conditions

Detailed Description

  • age
  • weight
  • high
  • BMI
  • pressure scanning map
  • Alimentary status
  • Diseases

Study Type

Observational

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

  • Israel
      • Tel Aviv, Israel, 69710
        • ASSUTAMC

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients from 18 y.o. before elective operation will be recruited for the study/ Any patient will be enroled in each group' seven in total according the BMI.

Description

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 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

Cohorts and Interventions

Group / Cohort
BMI 20 to 24.99
30 patients
BMI 25 to 29.99
30 patients
BMI 30 to 34.99
30 patients
BMI 35 to 39.99
30 patients
BMI 40 to 44.99
30 patients
BMI 45 to 49.99
30 patients
BMI more than 50
30 patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mapping body pressure
Time Frame: up to 6 month
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

Collaborators and Investigators

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

Sponsor

Assuta Medical Center

Investigators

  • Principal Investigator: Sergio G Susmallian, M.D., Assuta MC

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

June 1, 2014

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

April 10, 2014

First Submitted That Met QC Criteria

June 23, 2014

First Posted (Estimate)

June 25, 2014

Study Record Updates

Last Update Posted (Estimate)

March 29, 2016

Last Update Submitted That Met QC Criteria

March 28, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCO0414
  • relation of pressure in gender (Registry Identifier: BMI and pressure mapping)

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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