Pressure UlcerNCT05504980
The Effect of Repositioning Frequency Determined According to BMI on Pressure Ulcer Development Time
A study testing Repositioning in people with Pressure Ulcer, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
The research will be carried out in an experimental/randomized controlled manner in order to determine the effect of the frequency of repositioning according to body mass index on the development of pressure ulcers in adults. The sample size was determined as 66 people by power analysis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- Repositioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2022to 30 Jun 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Bedridden (1 and 2 points from the activity and movement subheadings of the Braden Risk Assessment Scale)
- Pressure ulcer not yet developed
- In the first 24 hours of hospitalization, it was evaluated according to the Braden Risk Assessment Scale and determined to be at high risk (range of 10-12 points) for the development of pressure ulcers
Who cannot join
- With hip fracture
- The position is not considered appropriate by the physician.
- Connected to Mechanical Ventilator
- Presence of septic shock
- Albumin value ≤3.5 mg/dl
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aydin Adnan Menderes University Research and Application Hospital
Aydin
About this study
Official title: The Effect of Repositioning Frequency Determined According to Body Mass Index on Pressure Ulcer Development Time: Randomized Controlled Trial
The research will be carried out in an experimental/randomized controlled manner in order to determine the effect of the frequency of repositioning according to body mass index on the development of pressure ulcers in adults.
The sample size was determined as 66 people by power analysis. However, considering the losses, the number of patients included in the sample will 30% higher than the calculated value and it was planned to include 86 patients (43 intervention group, 43 control group) in the study. In the first 24 hours of hospitalization, body mass index will be calculated by skinfold thickness measurement, and data will be collected using the "Structured Questionnaire" for patients with no pressure sores, bedridden, high and very high risk according to the Braden Risk Assessment Scale. In calculating the body mass index of bedridden patients, skinfold thickness measurement, measurement of the interface pressure, which is the most important factor in the development of pressure sores, and calf circumference measurement will be performed to determine the decrease in muscle mass. The research will continue with position change applications between 08-24 hours every day of the week. Patients in the intervention group will be given 30 degrees right lateral, supine, and 30 degrees left lateral positions, 1 hour apart, respectively. Patients in the control group will be given 30 degrees right lateral, supine and 30 degrees left lateral positions, respectively, at 2 hour intervals according to the hospital routine practice. In the initial evaluation, the interface pressure will be measured with the Palm Q-Portable Interface Pressure Sensor from the occipital, scapula, sacrum, heels when the patients are in the supine position, and from the pressure points of the acromion, greater thoracantary, and malleolus prominence when they are in the 30 degrees right and 30 degrees left lateral positions. Patients will be evaluated first within the first 24 hours of hospitalization and on day 21 if a pressure ulcer develops or does not develop a pressure sore a second time.
If the study is successful, it is expected that pressure ulcers will not develop in patients who are positioned at more frequent intervals.
Read the detailed description
Pressure sores usually occur with ischemia and cell death over bony prominences. It is one of the most common complications in bedridden patients in healthcare institutions worldwide. Its prevalence is used as a worldwide quality indicator and shows that pressure sores are a common health problem worldwide. Its incidence has been found in a wide range between 0% and 72.5% worldwide.
Pressure sores slow down the healing process, prolong the hospital stay, increase the risk of complications, and therefore adversely affect the quality of life of the patients. It increases the cost of maintenance and threatens life. Prevention of pressure sores and early diagnosis of possible tissue damage is important. For this, measures should be taken to eliminate or reduce the effects of risk factors by evaluating them correctly.
In the researches, the importance of body mass index, which plays a role in the development of pressure sores, has been determined. External pressure, which varies according to the body mass index, the physical characteristics of the patient and the characteristics of the support surface used, is the most important factor that plays a role in the development of pressure sores. Pressure sores occur due to external pressure.
The interface pressure, which occurs during the transmission of external pressure to the subcutaneous tissues between the support surface and the skin, may be different in people with different body structures. In studies, it is stated that collagen, muscle mass, adipose tissue density and body mass index around the capillaries affect the interface pressure. It is known that the density of collagen, muscle mass and adipose tissue is different in people with different body mass indexes.
It is important to keep the interface pressure low to allow the return of blood flow to prevent the formation of pressure-related wound.
For this, it is thought that by changing the frequency of repositioning, the interface pressure will prevent blood flow for a long time and tissue damage will be prevented.
- Conditions
- Pressure Ulcer
- Being tested
- Repositioning
- Keywords
- Nursing, Pressure ulcer, Body Mass Index, Reposition
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RepositioningProcedure or surgery
Patients in the intervention group will be given 30 degrees right lateral, supine, and 30 degrees left lateral positions, 1 hour apart, respectively.
| Study group | Role | What they receive |
|---|---|---|
| İntervention group | Experimental | Patients in the intervention group will be given 30 degrees right lateral, supine, and 30 degrees left lateral positions, 1 hour apart, respectively. Receives: Procedure: Repositioning |
| Control group | No intervention | Patients in the control group will be given 30 degrees right lateral, supine and 30 degrees left lateral positions, respectively, at 2 hour intervals according to the hospital routine practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of pressure ulcer development is changed in patients who are positioned more frequently.
If the study is successful, it is expected that the pressure ulcer development time will be prolonged or pressure ulcer will not develop in patients who are positioned more frequently.
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 posted17 Aug 2022
- Study start1 Jul 2022
- Primary completion31 Jan 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- 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
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Bulut, Aydin Adnan Menderes University
- Investigators
- Ebru Bulut, Researcher, Principal investigator, ResearcherZeynep Günes, Professor, Study director, Researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05504980
- Sponsor's protocol ID
- AdnanMenderesU
- Status last verified
- Aug 2024
- First submitted
- 3 Aug 2022
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kimura N, Nakagami G, Minematsu T, Sanada H. Non-invasive detection of local tissue responses to predict pressure ulcer development in mouse models. J Tissue Viability. 2020 Feb;29(1):51-57. doi: 10.1016/j.jtv.2019.11.001. Epub 2019 Nov 4.
PubMed 31757582Kim S, Kim M, Lee Y, Kim B, Yoon TY, Won CW. Calf Circumference as a Simple Screening Marker for Diagnosing Sarcopenia in Older Korean Adults: the Korean Frailty and Aging Cohort Study (KFACS). J Korean Med Sci. 2018 Apr 26;33(20):e151. doi: 10.3346/jkms.2018.33.e151. eCollection 2018 May 14.
PubMed 29760608Mervis JS, Phillips TJ. Pressure ulcers: Pathophysiology, epidemiology, risk factors, and presentation. J Am Acad Dermatol. 2019 Oct;81(4):881-890. doi: 10.1016/j.jaad.2018.12.069. Epub 2019 Jan 18.
PubMed 30664905Mervis JS, Phillips TJ. Pressure ulcers: Prevention and management. J Am Acad Dermatol. 2019 Oct;81(4):893-902. doi: 10.1016/j.jaad.2018.12.068. Epub 2019 Jan 18.
PubMed 30664906Seo Y, Roh YS. Effects of pressure ulcer prevention training among nurses in long-term care hospitals. Nurse Educ Today. 2020 Jan;84:104225. doi: 10.1016/j.nedt.2019.104225. Epub 2019 Oct 23.
PubMed 31698290Saghaleini SH, Dehghan K, Shadvar K, Sanaie S, Mahmoodpoor A, Ostadi Z. Pressure Ulcer and Nutrition. Indian J Crit Care Med. 2018 Apr;22(4):283-289. doi: 10.4103/ijccm.IJCCM_277_17.
PubMed 29743767Neloska L, Damevska K, Nikolchev A, Pavleska L, Petreska-Zovic B, Kostov M. The Association between Malnutrition and Pressure Ulcers in Elderly in Long-Term Care Facility. Open Access Maced J Med Sci. 2016 Sep 15;4(3):423-427. doi: 10.3889/oamjms.2016.094. Epub 2016 Aug 22.
PubMed 27703567Hyun S, Li X, Vermillion B, Newton C, Fall M, Kaewprag P, Moffatt-Bruce S, Lenz ER. Body mass index and pressure ulcers: improved predictability of pressure ulcers in intensive care patients. Am J Crit Care. 2014 Nov;23(6):494-500; quiz 501. doi: 10.4037/ajcc2014535.
PubMed 25362673Coleman S, Nixon J, Keen J, Wilson L, McGinnis E, Dealey C, Stubbs N, Farrin A, Dowding D, Schols JM, Cuddigan J, Berlowitz D, Jude E, Vowden P, Schoonhoven L, Bader DL, Gefen A, Oomens CW, Nelson EA. A new pressure ulcer conceptual framework. J Adv Nurs. 2014 Oct;70(10):2222-34. doi: 10.1111/jan.12405. Epub 2014 Mar 31.
PubMed 24684197Bhattacharya S, Mishra RK. Pressure ulcers: Current understanding and newer modalities of treatment. Indian J Plast Surg. 2015 Jan-Apr;48(1):4-16. doi: 10.4103/0970-0358.155260.
PubMed 25991879
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Repositioning Frequency Determined According to Body Mass Index on Pressure Ulcer Development Time: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05504980
- Acronym / sponsor ID
- AdnanMenderesU
- Conditions
- Pressure Ulcer
- Keywords
- Nursing, Pressure ulcer, Body Mass Index, Reposition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 17 Aug 2022 (actual)
- 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.
The research will be carried out in an experimental/randomized controlled manner in order to determine the effect of the frequency of repositioning according to body mass index on the development of pressure ulcers in adults.
The sample size was determined as 66 people by power analysis. However, considering the losses, the number of patients included in the sample will 30% higher than the calculated value and it was planned to include 86 patients (43 intervention group, 43 control group) in the study. In the first 24 hours of hospitalization, body mass index will be calculated by skinfold thickness measurement, and data will be collected using the "Structured Questionnaire" for patients with no pressure sores, bedridden, high and very high risk according to the Braden Risk Assessment Scale. In calculating the body mass index of bedridden patients, skinfold thickness measurement, measurement of the interface pressure, which is the most important factor in the development of pressure sores, and calf circumference measurement will be performed to determine the decrease in muscle mass. The research will continue with position change applications between 08-24 hours every day of the week. Patients in the intervention group will be given 30 degrees right lateral, supine, and 30 degrees left lateral positions, 1 hour apart, respectively. Patients in the control group will be given 30 degrees right lateral, supine and 30 degrees left lateral positions, respectively, at 2 hour intervals according to the hospital routine practice. In the initial evaluation, the interface pressure will be measured with the Palm Q-Portable Interface Pressure Sensor from the occipital, scapula, sacrum, heels when the patients are in the supine position, and from the pressure points of the acromion, greater thoracantary, and malleolus prominence when they are in the 30 degrees right and 30 degrees left lateral positions. Patients will be evaluated first within the first 24 hours of hospitalization and on day 21 if a pressure ulcer develops or does not develop a pressure sore a second time.
If the study is successful, it is expected that pressure ulcers will not develop in patients who are positioned at more frequent intervals.
Detailed description
Pressure sores usually occur with ischemia and cell death over bony prominences. It is one of the most common complications in bedridden patients in healthcare institutions worldwide. Its prevalence is used as a worldwide quality indicator and shows that pressure sores are a common health problem worldwide. Its incidence has been found in a wide range between 0% and 72.5% worldwide.
Pressure sores slow down the healing process, prolong the hospital stay, increase the risk of complications, and therefore adversely affect the quality of life of the patients. It increases the cost of maintenance and threatens life. Prevention of pressure sores and early diagnosis of possible tissue damage is important. For this, measures should be taken to eliminate or reduce the effects of risk factors by evaluating them correctly.
In the researches, the importance of body mass index, which plays a role in the development of pressure sores, has been determined. External pressure, which varies according to the body mass index, the physical characteristics of the patient and the characteristics of the support surface used, is the most important factor that plays a role in the development of pressure sores. Pressure sores occur due to external pressure.
The interface pressure, which occurs during the transmission of external pressure to the subcutaneous tissues between the support surface and the skin, may be different in people with different body structures. In studies, it is stated that collagen, muscle mass, adipose tissue density and body mass index around the capillaries affect the interface pressure. It is known that the density of collagen, muscle mass and adipose tissue is different in people with different body mass indexes.
It is important to keep the interface pressure low to allow the return of blood flow to prevent the formation of pressure-related wound.
For this, it is thought that by changing the frequency of repositioning, the interface pressure will prevent blood flow for a long time and tissue damage will be prevented.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| İntervention group | Experimental | Procedure: RepositioningPatients in the intervention group will be given 30 degrees right lateral, supine, and 30 degrees left lateral positions, 1 hour apart, respectively. |
| Control group | No intervention | –Patients in the control group will be given 30 degrees right lateral, supine and 30 degrees left lateral positions, respectively, at 2 hour intervals according to the hospital routine practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Bedridden (1 and 2 points from the activity and movement subheadings of the Braden Risk Assessment Scale)
- Pressure ulcer not yet developed
- In the first 24 hours of hospitalization, it was evaluated according to the Braden Risk Assessment Scale and determined to be at high risk (range of 10-12 points) for the development of pressure ulcers
Key exclusion criteria (5 listed)
- With hip fracture
- The position is not considered appropriate by the physician.
- Connected to Mechanical Ventilator
- Presence of septic shock
- Albumin value ≤3.5 mg/dl
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 |
|---|---|---|
| RepositioningPatients in the intervention group will be given 30 degrees right lateral, supine, and 30 degrees left lateral positions, 1 hour apart, respectively. | Procedure or surgery | İntervention group |
Primary outcome
The rate of pressure ulcer development is changed in patients who are positioned more frequently.
Time frame: 21 days
If the study is successful, it is expected that the pressure ulcer development time will be prolonged or pressure ulcer will not develop in patients who are positioned more frequently.
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 28 Aug 2024.
- Results publication: PubMed 31757582Kimura N, Nakagami G, Minematsu T, Sanada H. Non-invasive detection of local tissue responses to predict pressure ulcer development in mouse models. J Tissue Viability. 2020 Feb;29(1):51-57. doi: 10.1016/j.jtv.2019.11.001. Epub 2019 Nov 4.
- Results publication: PubMed 29760608Kim S, Kim M, Lee Y, Kim B, Yoon TY, Won CW. Calf Circumference as a Simple Screening Marker for Diagnosing Sarcopenia in Older Korean Adults: the Korean Frailty and Aging Cohort Study (KFACS). J Korean Med Sci. 2018 Apr 26;33(20):e151. doi: 10.3346/jkms.2018.33.e151. eCollection 2018 May 14.
- Results publication: PubMed 30664905Mervis JS, Phillips TJ. Pressure ulcers: Pathophysiology, epidemiology, risk factors, and presentation. J Am Acad Dermatol. 2019 Oct;81(4):881-890. doi: 10.1016/j.jaad.2018.12.069. Epub 2019 Jan 18.
- Results publication: PubMed 30664906Mervis JS, Phillips TJ. Pressure ulcers: Prevention and management. J Am Acad Dermatol. 2019 Oct;81(4):893-902. doi: 10.1016/j.jaad.2018.12.068. Epub 2019 Jan 18.
- Results publication: PubMed 31698290Seo Y, Roh YS. Effects of pressure ulcer prevention training among nurses in long-term care hospitals. Nurse Educ Today. 2020 Jan;84:104225. doi: 10.1016/j.nedt.2019.104225. Epub 2019 Oct 23.
- Results publication: PubMed 29743767Saghaleini SH, Dehghan K, Shadvar K, Sanaie S, Mahmoodpoor A, Ostadi Z. Pressure Ulcer and Nutrition. Indian J Crit Care Med. 2018 Apr;22(4):283-289. doi: 10.4103/ijccm.IJCCM_277_17.
- Results publication: PubMed 27703567Neloska L, Damevska K, Nikolchev A, Pavleska L, Petreska-Zovic B, Kostov M. The Association between Malnutrition and Pressure Ulcers in Elderly in Long-Term Care Facility. Open Access Maced J Med Sci. 2016 Sep 15;4(3):423-427. doi: 10.3889/oamjms.2016.094. Epub 2016 Aug 22.
- Results publication: PubMed 25362673Hyun S, Li X, Vermillion B, Newton C, Fall M, Kaewprag P, Moffatt-Bruce S, Lenz ER. Body mass index and pressure ulcers: improved predictability of pressure ulcers in intensive care patients. Am J Crit Care. 2014 Nov;23(6):494-500; quiz 501. doi: 10.4037/ajcc2014535.
- Results publication: PubMed 24684197Coleman S, Nixon J, Keen J, Wilson L, McGinnis E, Dealey C, Stubbs N, Farrin A, Dowding D, Schols JM, Cuddigan J, Berlowitz D, Jude E, Vowden P, Schoonhoven L, Bader DL, Gefen A, Oomens CW, Nelson EA. A new pressure ulcer conceptual framework. J Adv Nurs. 2014 Oct;70(10):2222-34. doi: 10.1111/jan.12405. Epub 2014 Mar 31.
- Results publication: PubMed 25991879Bhattacharya S, Mishra RK. Pressure ulcers: Current understanding and newer modalities of treatment. Indian J Plast Surg. 2015 Jan-Apr;48(1):4-16. doi: 10.4103/0970-0358.155260.
- Individual participant dataSharing planned: No
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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.
Ebru Bulut, Researcher principal investigator
Researcher
Zeynep Günes, Professor study director
Researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repositioning in people with Pressure Ulcer, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
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 3 inclusion and 5 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 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The rate of pressure ulcer development is changed in patients who are positioned more frequently. (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05504980, which also lists 10 linked publications.
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 28 Aug 2024.