NCT02173431

Brief 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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 25, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 29, 2016

Status Verified

March 1, 2016

Enrollment Period

6 months

First QC Date

April 10, 2014

Last Update Submit

March 28, 2016

Conditions

Pressure Ulcer Stage 1

Keywords

BMIPressureBedsore

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (7)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Any patient admitted for elective surgery,
  • Patients above 18 y.o.,
  • Patient admitted for surgery that required 3 or more days in hospital

You may not qualify if:

  • Patients under 18
  • Patients that require emergency surgery
  • Patients that have bedsores before admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASSUTAMC

Tel Aviv, 69710, Israel

Location

Biospecimen

Retention: NONE RETAINED

messure of pressure of patients resting on the buttres with pressure sensors

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Sergio G Susmallian, M.D.

    ASSUTA MC

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 10, 2014

First Posted

June 25, 2014

Study Start

June 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

March 29, 2016

Record last verified: 2016-03

Locations

IL(1)