NCT05504980

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

Completed NA Last updated 28 August 2024

What this trial tests

NA trial testing Repositioning in Pressure Ulcer in 71 participants. Completed in 30 June 2023.

Timeline

1 July 2022

Primary endpoint
31 January 2023

30 June 2023

Quick facts

Lead sponsor	Aydin Adnan Menderes University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	71
Start date	1 July 2022
Primary completion	31 January 2023
Estimated completion	30 June 2023
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Repositioning

Conditions studied

• Pressure Ulcer — all drugs for Pressure Ulcer →

Sponsor

Aydin Adnan Menderes University

Who can join

18 and older, any sex, with Pressure Ulcer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.