Pressure InjuryICU PI ColorsNCT07470918
The Effect of a Color-Coded System on Pressure Injury Prevention in the Intensive Care Unit
A study testing Color-Coded Pressure Injury Risk Assessment Group in people with Pressure Injury and Pressure Injury Prevention, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pressure Injury, Pressure Injury Prevention, Risk Assessment
- What is being tested?
- Color-Coded Pressure Injury Risk Assessment Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2026to 15 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Agreeing to participate in the study
- Participants who do not have a pre-existing pressure injury upon hospital admission
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
University of Health Sciences Turkiye Gulhane Faculty of Nursing
Ankara
About this study
Official title: The Effect of Using a Color-Coded Classification System on Pressure Injury Development in the Prevention of Pressure Injury in the Intensive Care Unit
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.
Read the detailed description
Pressure injuries, generally defined as localized injuries resulting from pressure or friction accompanied by pressure and/or tearing/rupture in the skin and/or deep tissues over bony prominences, are one of the most significant health problems in healthcare services worldwide, both for individuals and institutions. In pressure injuries, the primary roles of nurses are to assess individuals at risk using valid and reliable risk assessment tools, take measures to eliminate causative factors, protect and maintain skin integrity, and prevent the development of pressure injuries; and, when a pressure injury develops, to provide nursing care in collaboration with the individual and their family, taking into account individual characteristics, to promote healing and prevent recurrence.
Since pressure injuries are largely preventable, identifying individuals at the highest risk and providing timely preventive care is crucial. Many valid and reliable risk assessment tools have been developed to identify individuals in the high-risk group. However, there is much debate in the literature regarding the benefits of pressure injury risk assessment tools. One of these debates is that the tools used by nurses to assess the risk of pressure injuries require a great deal of time, energy, and effort. Furthermore, the literature suggests that these tools should be presented in a user-friendly format to encourage clinicians to use them. A study by Creehan and Brindle found that nurses frequently record a risk score for pressure injuries in their records but often fail to implement interventions.
A review of the literature reveals that the lack of user-friendly formats in risk assessment tools used in intensive care units to prevent pressure injuries, inconsistencies in interpreting the separate categories causing pressure injuries, and the insufficient reflection of risk scores obtained in risk assessments in nursing care are identified as obstacles to preventing pressure injuries. Moreover, the number of applications developed to address these problems is quite limited in the literature.
The study will be conducted as a prospective randomized controlled trial. After obtaining verbal and written consent from individuals before and after clinical intervention, the study will be conducted using various data collection forms.
These forms are: Braden Pressure Injury Risk Assessment Scale, Color-Coded Braden Pressure Injury Risk Assessment Scale, Participant Identification Form, Skin Assessment Form, Pressure Injury Incidence Monitoring Form, and Position Monitoring-Control Form. Participants will be randomized.
Color-Coded Braden Pressure Injury Risk Assessment Scale group in group-I (n=48), and group II (n=48) will be the control group.
In the first stage; pressure injury risk score for individuals in Group I (n=48) will be determined using the Color-Coded Braden Pressure Injury Risk Assessment Scale, and the pressure injury risk score for individuals in Group II (n=48) will be determined using the Braden Pressure Injury Risk Assessment Scale. The defining characteristics of individuals in Group-I and Group-II, whose risk scores have been determined, will be recorded on the Participant Identification Form.
Color-coded pressure injury risk levels for individuals in Group I 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. This application aims to enable nurses to quickly and visually identify pressure injury risks in patients. The skin condition of individuals identified by color codes will be observed and recorded on the Skin Assessment Form. The development of possible pressure injuries will be monitored using the Pressure Injury Incidence Monitoring Form, and the frequency of position changes will be monitored using the Position Monitoring-Control Form.
Individuals in Group II, whose risk level for pressure injuries is determined using the Braden Pressure Injury Risk Assessment Scale, will have their skin condition observed and recorded on the Skin Assessment Form. Pressure injuries will be monitored using the Pressure Injury Incidence Monitoring Form, and the regularity of position changes will be monitored using the Position Monitoring-Control Form.
- Being tested
- Color-Coded Pressure Injury Risk Assessment Group
- Keywords
- Pressure Injury, Braden Scale, Pressure Injury Prevention, Evidence-Based Nursing, Pressure Injury Risk Assessment, Nursing Care
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Color-Coded Pressure Injury Risk Assessment GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the hospital stay, assessments are conducted every 24 hours from day 1 to day 5 of hospital admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start15 Jan 2026
- Primary completion15 Apr 2026 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pressure InjuryStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ece Nur Aykenar, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07470918
- Sponsor's protocol ID
- 12121212
- Acronym
- ICU PI Colors
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34605185Gedamu 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.
PubMed 34381901Kottner 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.
PubMed 30658878Kim 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.
PubMed 34972856Creehan 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.
PubMed 21844780
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using a Color-Coded Classification System on Pressure Injury Development in the Prevention of Pressure Injury in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT07470918
- Acronym / sponsor ID
- ICU PI Colors / 12121212
- Keywords
- Pressure Injury, Braden Scale, Pressure Injury Prevention, Evidence-Based Nursing, Pressure Injury Risk Assessment, Nursing Care
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Pressure injuries, generally defined as localized injuries resulting from pressure or friction accompanied by pressure and/or tearing/rupture in the skin and/or deep tissues over bony prominences, are one of the most significant health problems in healthcare services worldwide, both for individuals and institutions. In pressure injuries, the primary roles of nurses are to assess individuals at risk using valid and reliable risk assessment tools, take measures to eliminate causative factors, protect and maintain skin integrity, and prevent the development of pressure injuries; and, when a pressure injury develops, to provide nursing care in collaboration with the individual and their family, taking into account individual characteristics, to promote healing and prevent recurrence.
Since pressure injuries are largely preventable, identifying individuals at the highest risk and providing timely preventive care is crucial. Many valid and reliable risk assessment tools have been developed to identify individuals in the high-risk group. However, there is much debate in the literature regarding the benefits of pressure injury risk assessment tools. One of these debates is that the tools used by nurses to assess the risk of pressure injuries require a great deal of time, energy, and effort. Furthermore, the literature suggests that these tools should be presented in a user-friendly format to encourage clinicians to use them. A study by Creehan and Brindle found that nurses frequently record a risk score for pressure injuries in their records but often fail to implement interventions.
A review of the literature reveals that the lack of user-friendly formats in risk assessment tools used in intensive care units to prevent pressure injuries, inconsistencies in interpreting the separate categories causing pressure injuries, and the insufficient reflection of risk scores obtained in risk assessments in nursing care are identified as obstacles to preventing pressure injuries. Moreover, the number of applications developed to address these problems is quite limited in the literature.
The study will be conducted as a prospective randomized controlled trial. After obtaining verbal and written consent from individuals before and after clinical intervention, the study will be conducted using various data collection forms.
These forms are: Braden Pressure Injury Risk Assessment Scale, Color-Coded Braden Pressure Injury Risk Assessment Scale, Participant Identification Form, Skin Assessment Form, Pressure Injury Incidence Monitoring Form, and Position Monitoring-Control Form. Participants will be randomized.
Color-Coded Braden Pressure Injury Risk Assessment Scale group in group-I (n=48), and group II (n=48) will be the control group.
In the first stage; pressure injury risk score for individuals in Group I (n=48) will be determined using the Color-Coded Braden Pressure Injury Risk Assessment Scale, and the pressure injury risk score for individuals in Group II (n=48) will be determined using the Braden Pressure Injury Risk Assessment Scale. The defining characteristics of individuals in Group-I and Group-II, whose risk scores have been determined, will be recorded on the Participant Identification Form.
Color-coded pressure injury risk levels for individuals in Group I 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. This application aims to enable nurses to quickly and visually identify pressure injury risks in patients. The skin condition of individuals identified by color codes will be observed and recorded on the Skin Assessment Form. The development of possible pressure injuries will be monitored using the Pressure Injury Incidence Monitoring Form, and the frequency of position changes will be monitored using the Position Monitoring-Control Form.
Individuals in Group II, whose risk level for pressure injuries is determined using the Braden Pressure Injury Risk Assessment Scale, will have their skin condition observed and recorded on the Skin Assessment Form. Pressure injuries will be monitored using the Pressure Injury Incidence Monitoring Form, and the regularity of position changes will be monitored using the Position Monitoring-Control Form.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Color-Coded Pressure Injury Risk Assessment Group | Experimental | Other: Color-Coded Pressure Injury Risk Assessment GroupParticipants' 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Agreeing to participate in the study
- Participants who do not have a pre-existing pressure injury upon hospital admission
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Color-Coded Pressure Injury Risk Assessment GroupColor-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. | Other | Color-Coded Pressure Injury Risk Assessment Group |
Primary outcome
Hospital-Acquired Pressure Injury Incidence
Time frame: During the hospital stay, assessments are conducted every 24 hours from day 1 to day 5 of hospital admission.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Background: PubMed 34605185Tervo-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.
- Background: PubMed 34381901Gedamu 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.
- Background: PubMed 30658878Kottner 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.
- Background: PubMed 34972856Kim 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.
- Background: PubMed 21844780Creehan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Color-Coded Pressure Injury Risk Assessment Group in people with Pressure Injury and Pressure Injury Prevention, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital-Acquired Pressure Injury Incidence (time frame: During the hospital stay, assessments are conducted every 24 hours from day 1 to day 5 of hospital admission.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07470918, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.