NCT02479425

Brief Summary

Several studies were searched the preventive measures of bed sores. Although repositioning is the mainstay in most preventive measures, there is no evidence to recommend specific turning regimen. The aim of this study is to comparative the impact of the two points repositioning in lateral lying position on the right and left versus the traditional three points repositioning on the right, back, and left in the occurrence of bed sores. This study was conducted on 150 patients admitted to the critical care department of Alexandria Main University Hospital after obtaining an informed consent from their relatives. The investigators excluded patients who: have active or healed bed sores. Patients were randomly divided into two groups by allocated randomization:

  • Group 1: traditional three points rotation.
  • Group 2: two points rotation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2011

Status
completed

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

Study Start

First participant enrolled

May 1, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed
Last Updated

July 8, 2015

Status Verified

July 1, 2015

Enrollment Period

10 months

First QC Date

June 10, 2015

Last Update Submit

July 5, 2015

Conditions

Pressure Ulcer

Keywords

pressure ulcerPositioning

Outcome Measures

Primary Outcomes (1)

  • pressure ulcer occurence

    incidence

    21 days

Study Arms (2)

3 point turning

ACTIVE COMPARATOR

patients nursed by the traditional re-positioning (two hours on back, two hours on right and two hours on left).

Procedure: patient positioning

2 points turning

EXPERIMENTAL

patients nursed on the right and left side sonly in 30ْ avoiding the back

Procedure: patient positioning

Interventions

patient positioningPROCEDURE

positioning patients, every 2 hours, either to standard (right, back, left sides) or only to right and left sides

2 points turning3 point turning

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients admitted to critical care medicine department and expected to have long stay

You may not qualify if:

  • active or healed bed sores

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Patient Positioning

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ahmed M El-Mehalawy, MD, lecturer of Critical Care Medicine

Study Record Dates

First Submitted

June 10, 2015

First Posted

June 24, 2015

Study Start

May 1, 2011

Primary Completion

March 1, 2012

Study Completion

July 1, 2012

Last Updated

July 8, 2015

Record last verified: 2015-07