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

Primary Purpose

Pressure Ulcer

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Repositioning
Sponsored by
Aydin Adnan Menderes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pressure Ulcer focused on measuring Nursing, Pressure ulcer, Body Mass Index, Reposition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Aydin Adnan Menderes University Research and Application HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

İntervention group

Control group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 3, 2022
Last Updated
August 17, 2022
Sponsor
Aydin Adnan Menderes University
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1. Study Identification

Unique Protocol Identification Number
NCT05504980
Brief Title
The Effect of Repositioning Frequency Determined According to BMI on Pressure Ulcer Development Time
Official Title
The Effect of Repositioning Frequency Determined According to Body Mass Index on Pressure Ulcer Development Time: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aydin Adnan Menderes University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer
Keywords
Nursing, Pressure ulcer, Body Mass Index, Reposition

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
İntervention group
Arm Type
Experimental
Arm Description
Patients in the intervention group will be given 30 degrees right lateral, supine, and 30 degrees left lateral positions, 1 hour apart, respectively.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Repositioning
Intervention Description
Patients in the intervention group will be given 30 degrees right lateral, supine, and 30 degrees left lateral positions, 1 hour apart, respectively.
Primary Outcome Measure Information:
Title
The rate of pressure ulcer development is changed in patients who are positioned more frequently.
Description
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.
Time Frame
21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ebru Bulut, Researcher
Phone
+90 256 218 00 00
Ext
2927
Email
ebru.bulut@adu.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Zeynep Günes, Professor
Phone
+90 256 218 00 00
Ext
2924
Email
zgunes@adu.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ebru Bulut, Researcher
Organizational Affiliation
Researcher
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zeynep Günes, Professor
Organizational Affiliation
Researcher
Official's Role
Study Director
Facility Information:
Facility Name
Aydin Adnan Menderes University Research and Application Hospital
City
Aydin
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ebru Bulut, Researcher
Phone
+90 256 218 00 00
Ext
2927
Email
ebru.bulut@adu.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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31757582
Citation
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Citation
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Citation
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The Effect of Repositioning Frequency Determined According to BMI on Pressure Ulcer Development Time

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