Pressure UlcerNCT02479425
Two Points Versus Three Points Turning in Prevention of Bed Sores in Critically Ill Patients
A study testing patient positioning in people with Pressure Ulcer, run by University of Alexandria.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- patient positioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients admitted to critical care medicine department and expected to have long stay
Who cannot join
- active or healed bed sores
About this study
Official title: Two Pints Versus Three Points Turning in Prevention of Bed Sores in Critically Ill Patients
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.
Read more
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.
Read the detailed 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
- Conditions
- Pressure Ulcer
- Being tested
- patient positioning
- Keywords
- pressure ulcer, Positioning
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient positioningProcedure or surgery
positioning patients, every 2 hours, either to standard (right, back, left sides) or only to right and left sides
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Procedure: patient positioning |
| 2 points turning | Experimental | patients nursed on the right and left side sonly in 30ْ avoiding the back Receives: Procedure: patient positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
pressure ulcer occurence
incidence
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startMay 2011
- Primary completionMar 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alexandria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed M El-Mehalawy, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02479425
- Sponsor's protocol ID
- Faculty of Medicine 09052011
- Status last verified
- Jul 2015
- First submitted
- 10 Jun 2015
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Pints Versus Three Points Turning in Prevention of Bed Sores in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT02479425
- Acronym / sponsor ID
- Faculty of Medicine 09052011
- Conditions
- Pressure Ulcer
- Keywords
- pressure ulcer, Positioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of AlexandriaUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 24 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 point turning | Active comparator | Procedure: patient positioningpatients nursed by the traditional re-positioning (two hours on back, two hours on right and two hours on left). |
| 2 points turning | Experimental | Procedure: patient positioningpatients nursed on the right and left side sonly in 30ْ avoiding the back |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients admitted to critical care medicine department and expected to have long stay
Key exclusion criteria (1 listed)
- active or healed bed sores
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patient positioningpositioning patients, every 2 hours, either to standard (right, back, left sides) or only to right and left sides | Procedure or surgery | 2 points turning, 3 point turning |
Primary outcome
pressure ulcer occurence
Time frame: 21 days
incidence
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing patient positioning in people with Pressure Ulcer, run by University of Alexandria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pressure ulcer occurence (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2015.