The Effect of a Color-Coded System on Pressure Injury Prevention in the Intensive Care Unit

NCT07470918 | Enrolling By Invitation

• 1 other identifier: 12121212
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed as a randomized controlled trial to examine the effect of using a color-coded classification system that identifies the risks of pressure injuries in the intensive care unit on the development of pressure injuries.

Conditions

Pressure Injury; Pressure Injury Prevention; Risk Assessment; Nursing Care

Keywords

Pressure Injury; Braden Scale; Pressure Injury Prevention; Evidence-Based Nursing; Pressure Injury Risk Assessment; Nursing Care

Outcome Measures

Primary Outcomes (1)

• Hospital-Acquired Pressure Injury Incidence

  The Color-Coded Braden Pressure Injury Risk Assessment Scale will be used to assess the risk of pressure injury in participants. This scale, which presents risk levels using a color-coded system, is expected to facilitate rapid risk identification and support timely preventive nursing interventions. The impact of this approach on pressure injury development and patient outcomes will be evaluated. This status will be evaluated with the Pressure Injury Frequency Monitoring Form, developed based on the European Pressure Ulcer Advisory Panel / National Pressure Injury Advisory Panel (2019) pressure injury staging system. All participants hospitalized in the unit will be assessed every 24 hours from the first day of their hospital admission until the 5th day. The presence or absence of pressure ulcers, time of onset, stage, anatomical location, and cause will be recorded.

  During the hospital stay, assessments are conducted every 24 hours from day 1 to day 5 of hospital admission.

Study Arms (2)

Color-Coded Pressure Injury Risk Assessment Group

EXPERIMENTAL

Participants' pressure injury risk will be assessed with the Color-Coded Braden Pressure Injury Risk Assessment Scale. Participants will be evaluated every 24 hours from the beginning of the 0th measurement time to the end of the 5th measurement time. Pressure injury status (present/absent), occurrence time, stage, location, and cause will be recorded.

Other: Color-Coded Pressure Injury Risk Assessment Group

No Intervention: Control Group

NO INTERVENTION

Participants' pressure injury risk will be assessed with the Braden Risk Assessment Scale. Participants will be evaluated every 24 hours from the beginning of the 0th measurement time to the end of the 5th measurement time. Pressure injury status (present/absent), occurrence time, stage, location, and cause will be recorded.

Interventions

Color-Coded Pressure Injury Risk Assessment Group OTHER

Color-coded pressure injury risk levels will be displayed at the bedside of the patient using color-coded cards: red indicates high risk, yellow indicates medium risk, and green indicates low risk. Participants will be evaluated every 24 hours from the beginning of the 0th measurement time to the end of the 5th measurement time. Pressure injury status (present/absent), occurrence time, stage, location, and cause will be recorded.

Color-Coded Pressure Injury Risk Assessment Group

Eligibility Criteria

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

You may qualify if:

• Agreeing to participate in the study
• Participants who do not have a pre-existing pressure injury upon hospital admission

You may not qualify if:

• Wanting to withdraw from the study
• Discharge from hospital or change of department before completing the number of days determined during the data collection phase

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

University of Health Sciences Turkiye Gulhane Faculty of Nursing

Ankara, Turkey (Türkiye)

Location

Related Publications (5)

• Tervo-Heikkinen TA, Heikkila A, Koivunen M, Kortteisto TR, Peltokoski J, Salmela S, Sankelo M, Ylitormanen TS, Junttila K. Pressure injury prevalence and incidence in acute inpatient care and related risk factors: A cross-sectional national study. Int Wound J. 2022 May;19(4):919-931. doi: 10.1111/iwj.13692. Epub 2021 Oct 4.

  PMID: 34605185 BACKGROUND

• Gedamu H, Abate T, Ayalew E, Tegenaw A, Birhanu M, Tafere Y. Level of nurses' knowledge on pressure ulcer prevention: A systematic review and meta-analysis study in Ethiopia. Heliyon. 2021 Jul 22;7(7):e07648. doi: 10.1016/j.heliyon.2021.e07648. eCollection 2021 Jul.

  PMID: 34381901 BACKGROUND

• Kottner J, Cuddigan J, Carville K, Balzer K, Berlowitz D, Law S, Litchford M, Mitchell P, Moore Z, Pittman J, Sigaudo-Roussel D, Yee CY, Haesler E. Prevention and treatment of pressure ulcers/injuries: The protocol for the second update of the international Clinical Practice Guideline 2019. J Tissue Viability. 2019 May;28(2):51-58. doi: 10.1016/j.jtv.2019.01.001. Epub 2019 Jan 11.

  PMID: 30658878 BACKGROUND

• Kim P, Aribindi VK, Shui AM, Deshpande SS, Rangarajan S, Schorger K, Aldrich JM, Lee H. Risk Factors for Hospital-Acquired Pressure Injury in Adult Critical Care Patients. Am J Crit Care. 2022 Jan 1;31(1):42-50. doi: 10.4037/ajcc2022657.

  PMID: 34972856 BACKGROUND

• Creehan SM, Brindle TC. Stoplight system for pressure ulcer risk assessment. Nursing. 2011 Sep;41(9):67; quiz 68. doi: 10.1097/01.NURSE.0000403275.14170.4b. No abstract available.

  PMID: 21844780 BACKGROUND

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

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: MSc Student

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 13, 2026
• Study Start: January 15, 2026
• Primary Completion: April 15, 2026
• Study Completion: May 15, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)