An interventional study of Control Group and Care Bundle Group in Medical Device Related Pressure Ulcer (MDRPU) and Pressure Injury, sponsored by Koç University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Koç University · Not applicable, Interventional, and Prevention
Medical device-related pressure injuries (MDRPIs) are an important and largely preventable patient safety problem, particularly in intensive care units where the use of medical devices is frequent and prolonged. A recent meta-analysis reported an MDRPI incidence of approximately 19% among adults in critical care settings. Although evidence-based recommendations for MDRPI prevention are available, their consistent and sustainable integration into routine nursing care remains challenging. Care bundles may facilitate the translation of evidence into routine clinical practice; however, existing MDRPI prevention bundles vary considerably in their components and implementation strategies, and evidence regarding their clinical and economic effectiveness remains limited.
This study aims to develop an artificial intelligence (AI)-synthesized nursing care bundle for the prevention of MDRPIs and to evaluate its clinical effectiveness and cost-effectiveness compared with routine care. The care bundle will consist of 3-5 evidence-based components identified through a systematic review of the literature and AI-assisted evidence synthesis. The draft bundle will subsequently be evaluated and finalized through a two-round Delphi process involving experts with experience in MDRPI prevention. Before clinical implementation, participating nurses will receive standardized training, and their adherence to the care bundle will be assessed by the research team, with an adherence level of ≥95% required before implementation.
The clinical effectiveness of the finalized care bundle will be evaluated in a randomized controlled trial conducted in an adult intensive care unit. A total of 220 patients will be allocated in a 1:1 ratio, using blocked stratified randomization based on MDRPI risk level, to either the intervention group receiving the AI-synthesized nursing care bundle or the control group receiving routine care. All medical devices in place at enrollment will be recorded, and participants will be followed for up to 14 days; the primary outcome will be the occurrence of an MDRPI related to these devices during the follow-up period. An economic evaluation will be conducted from the hospital perspective based on product utilization, nursing labor time, and hospitalization-related resource use, and the cost-effectiveness of the intervention will be assessed using the incremental cost-effectiveness ratio.
545 studies on the registry are indexed under Pressure Ulcer; 129 are open to participants now.
This study's planned enrollment of 220 is above the median of 70 across 405 interventional studies indexed under Pressure Ulcer.
Browse Pressure Ulcer studies →Koç University is the lead sponsor of 109 studies on the registry; 36 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants allocated to this group will receive the AI-synthesized nursing care bundle for the prevention of medical device-related pressure injuries (MDRPIs), in addition to the routine care provided in the intensive care unit.
Other: Care Bundle Group
Participants allocated to this group will receive the routine care currently provided in the intensive care unit.
Other: Control Group
Routine care includes general pressure injury risk assessment, daily skin assessment, and protective or preventive care measures applied according to individual clinical needs. No structured or standardized medical device-specific monitoring or care protocol is currently implemented in routine clinical practice in the unit.
Also known as: Routine Care
The intervention consists of a 3-5 component nursing care bundle developed through AI-assisted evidence synthesis and finalized through a two-round Delphi expert consensus process to prevent medical device-related pressure injuries (MDRPIs). The final bundle components and their implementation frequency will be defined before the clinical implementation phase and incorporated into the clinical protocol. The care bundle will be implemented by nurses who have completed standardized training and demonstrated an adherence rate of ≥95%, as assessed by the research team. Adherence to the care bundle will be monitored and documented using a standardized Care Bundle Monitoring Form throughout the intervention period.
Also known as: AI-Synthesized Nursing Care Bundle
Incidence of Medical device related pressure injury
Occurrence of at least one MDRPI (yes/no) related to the medical devices in place at enrollment. Skin and mucosa under and around each device will be assessed during daily visits, and MDRPIs will be documented using the Medical Device Monitoring and Pressure Injury Event Follow-up Form and staged according to the National Pressure Injury Advisory Panel (NPIAP) classification system. Incidence will be calculated as the proportion of patients developing an MDRPI among all patients with medical devices in each group.
Time frame: Up to 14 days after enrollment
Total cost per participant
Total cost per patient calculated from the hospital perspective, based on product utilization, nursing labor time for care bundle-related interventions, and hospitalization-related resource use. Product costs will be based on the hospital's unit purchase prices. Costs will be recorded prospectively using the MDRPI Cost Form and reported in Turkish Lira.
Time frame: Up to 14 days after enrollment
Plan to share: No — Individual participant data will not be shared, as the study involves sensitive patient health information and data sharing was not included in the informed consent obtained from participants or approved by the institutional ethics committee.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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