The Effect of Repositioning Frequency Determined According to BMI on Pressure Ulcer Development Time

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.

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Key information

Conditions

Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aydin Adnan Menderes University Research and Application Hospital

Aydin, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Repositioning

Procedure

Patients in the intervention group will be given 30 degrees right lateral, supine, and 30 degrees left lateral positions, 1 hour apart, respectively.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Official study title

The Effect of Repositioning Frequency Determined According to Body Mass Index on Pressure Ulcer Development Time: Randomized Controlled Trial

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Aug 17, 2022
Registry last updated: Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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