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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02479425
Other study ID # Faculty of Medicine 09052011
Secondary ID
Status Completed
Phase N/A
First received June 10, 2015
Last updated July 5, 2015
Start date May 2011
Est. completion date July 2012

Study information

Verified date July 2015
Source Faculty of Medicine, University of Alexandria
Contact n/a
Is FDA regulated No
Health authority Egypt: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Description:

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.

Aim of the study:

The aim of this study was designed to evaluate the comparative 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.

Patients:

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.

Methods:

The studied patients were subjected to:

Complete history taking, physical examination, primary ICU diagnosis, routine laboratory investigation and recording Glasgaw coma scale (GCS), use of sedation, vasopressors and mechanical ventilation

Patients in group 1 nursed by traditional protocol [ two hours on the right side in 30 degree lateral position, two hours on the back and two hours on the left side in 30 degree lateral position] Patients in group 2 nursed in lateral position with 30 degree two hours on the right and two hours on the left with elevation of the head of bed by 30 degree in the two groups.

both groups were monitored for bed sores incidence, timing and sites of occurence


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date July 2012
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- active or healed bed sores

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Faculty of Medicine, University of Alexandria

Outcome

Type Measure Description Time frame Safety issue
Primary pressure ulcer occurence incidence 21 days No
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