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

NCT05504980 | Completed DMC

• 1 other identifier: AdnanMenderesU
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Pressure Ulcer

Keywords

Nursing; Pressure ulcer; Body Mass Index; Reposition

Outcome Measures

Primary Outcomes (1)

• 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.

  21 days

Study Arms (2)

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.

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.

Interventions

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.

İntervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Aydin Adnan Menderes University Research and Application Hospital

Aydin, Turkey (Türkiye)

Location

Related Publications (10)

• 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.

  PMID: 31757582 RESULT

• Kim 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.

  PMID: 29760608 RESULT

• Mervis 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.

  PMID: 30664905 RESULT

• Mervis 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.

  PMID: 30664906 RESULT

• Seo 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.

  PMID: 31698290 RESULT

• Saghaleini 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.

  PMID: 29743767 RESULT

• Neloska 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.

  PMID: 27703567 RESULT

• Hyun 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.

  PMID: 25362673 RESULT

• Coleman 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.

  PMID: 24684197 RESULT

• Bhattacharya 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.

  PMID: 25991879 RESULT

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ebru Bulut, Researcher

  Researcher

  PRINCIPAL INVESTIGATOR

• Zeynep Günes, Professor

  Researcher

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: August 17, 2022
• Study Start: July 1, 2022
• Primary Completion: January 31, 2023
• Study Completion: June 30, 2023
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)