Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-05 @ 10:24 PM
Study NCT ID:
NCT07470918
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-03-17
First Post:
2026-03-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of a Color-Coded System on Pressure Injury Prevention in the Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003668', 'term': 'Pressure Ulcer'}], 'ancestors': [{'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-05-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-13', 'studyFirstSubmitDate': '2026-03-10', 'studyFirstSubmitQcDate': '2026-03-10', 'lastUpdatePostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital-Acquired Pressure Injury Incidence', 'timeFrame': 'During the hospital stay, assessments are conducted every 24 hours from day 1 to day 5 of hospital admission.', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pressure Injury', 'Braden Scale', 'Pressure Injury Prevention', 'Evidence-Based Nursing', 'Pressure Injury Risk Assessment', 'Nursing Care'], 'conditions': ['Pressure Injury', 'Pressure Injury Prevention', 'Risk Assessment', 'Nursing Care']}, 'referencesModule': {'references': [{'pmid': '34605185', 'type': 'BACKGROUND', 'citation': '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': '34381901', 'type': 'BACKGROUND', 'citation': "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': '30658878', 'type': 'BACKGROUND', 'citation': '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': '34972856', 'type': 'BACKGROUND', 'citation': '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': '21844780', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nSince 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.\n\nA 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.\n\nThe 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.\n\nThese 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.\n\nColor-Coded Braden Pressure Injury Risk Assessment Scale group in group-I (n=48), and group II (n=48) will be the control group.\n\nIn 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.\n\nColor-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.\n\nIndividuals 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Agreeing to participate in the study\n* Participants who do not have a pre-existing pressure injury upon hospital admission\n\nExclusion Criteria:\n\n* Wanting to withdraw from the study\n* Discharge from hospital or change of department before completing the number of days determined during the data collection phase'}, 'identificationModule': {'nctId': 'NCT07470918', 'acronym': 'ICU PI Colors', 'briefTitle': 'The Effect of a Color-Coded System on Pressure Injury Prevention in the Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'Saglik Bilimleri Universitesi'}, 'officialTitle': 'The Effect of Using a Color-Coded Classification System on Pressure Injury Development in the Prevention of Pressure Injury in the Intensive Care Unit', 'orgStudyIdInfo': {'id': '12121212'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Color-Coded Pressure Injury Risk Assessment Group', 'description': "Participants' pressure injury risk will be assessed with the Color-Coded Braden Pressure Injury Risk Assessment Scale.\n\nParticipants 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.", 'interventionNames': ['Other: Color-Coded Pressure Injury Risk Assessment Group']}, {'type': 'NO_INTERVENTION', 'label': 'No Intervention: Control Group', 'description': "Participants' pressure injury risk will be assessed with the Braden Risk Assessment Scale.\n\nParticipants 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': [{'name': 'Color-Coded Pressure Injury Risk Assessment Group', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Color-Coded Pressure Injury Risk Assessment Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'University of Health Sciences Turkiye Gulhane Faculty of Nursing', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saglik Bilimleri Universitesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MSc Student', 'investigatorFullName': 'Ece Nur Aykenar', 'investigatorAffiliation': 'Saglik Bilimleri Universitesi'}}}}