Medical Device Related Pressure Ulcer (MDRPU)NCT07789613
Clinical and Cost-Effectiveness of an Artificial Intelligence -Synthesized Nursing Care Bundle for Preventing Medical Device-Related Pressure Injuries
A study testing Care Bundle Group in people with Medical Device Related Pressure Ulcer (MDRPU) and Pressure Injury, run by Koç University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medical Device Related Pressure Ulcer (MDRPU), Pressure Injury
- What is being tested?
- Care Bundle Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2026to 15 Jul 2027
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older
- Presence of at least one medical device placed for diagnostic or therapeutic purposes.
- No existing medical device-related pressure injury (MDRPI) at the time of study enrollment.
- Expected length of stay in the intensive care unit of at least 24 hours.
- Willingness to participate in the study and provision of written informed consent by the participant or their legal representative.
Who cannot join
- Presence of only a peripheral intravenous (IV) catheter as a medical device. (Peripheral IV catheters are excluded because they are routinely present in ICU patients and their replacement frequency and treatment-related use may vary rapidly and unpredictably)
- Presence of an existing MDRPI at the time of study enrollment.
- Expected intensive care unit stay of less than 24 hours.
- Refusal to participate, failure to provide informed consent, or withdrawal of consent during the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ayişe Karadağ, Professor contact
Turkey (Türkiye)1 site
Koc University Hospital
Istanbul, Zeytinburnu, 34010
About this study
Official title: The Clinical and Cost-Effectiveness of an Artificial Intelligence-Synthesized Nursing Care Bundle in Preventing Medical Device-Related Pressure Injuries
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.
- Being tested
- Control Group, Care Bundle Group
- Keywords
- care bundle, cost, medical devices related pressure injury, randomised controlled trial, nursing care bundle, artificial intelligence, evidence based practice
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control GroupOther
Also called Routine Care
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.
Care Bundle GroupOther
Also called AI-Synthesized Nursing Care Bundle
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.
| Study group | Role | What they receive |
|---|---|---|
| AI-Synthesized Nursing Care Bundle | Experimental | 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. Receives: Other: Care Bundle Group |
| Routine Care | Active comparator | Participants allocated to this group will receive the routine care currently provided in the intensive care unit. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 14 days after enrollment
Secondary outcomes (1)
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.
Measured: Up to 14 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start15 Sep 2026 (estimated)
- Primary completion15 Mar 2027 (estimated)
- Study completion15 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Medical Device Related Pressure Ulcer (MDRPU)Studies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07789613
- Sponsor's protocol ID
- 2025.448.IRB2.202
- Other IDs
- 226S149
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Neill S, Martin D. Nursing care bundles in the prevention of medical device related pressure ulcers: An integrative review. J Tissue Viability. 2024 Aug;33(3):376-386. doi: 10.1016/j.jtv.2024.04.003. Epub 2024 Apr 10.
PubMed 38641481Zhang N, Li Y, Li X, Li F, Jin Z, Li T, Ma J. Incidence of medical device-related pressure injuries: a meta-analysis. Eur J Med Res. 2024 Aug 19;29(1):425. doi: 10.1186/s40001-024-01986-2.
PubMed 39155379
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical and Cost-Effectiveness of an Artificial Intelligence-Synthesized Nursing Care Bundle in Preventing Medical Device-Related Pressure Injuries
- ClinicalTrials.gov ID
- NCT07789613
- Acronym / sponsor ID
- 2025.448.IRB2.202
- Keywords
- care bundle, cost, medical devices related pressure injury, randomised controlled trial, nursing care bundle, artificial intelligence, evidence based practice
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 27 Aug 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-Synthesized Nursing Care Bundle | Experimental | Other: Care Bundle GroupParticipants 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. |
| Routine Care | Active comparator | Other: Control GroupParticipants allocated to this group will receive the routine care currently provided in the intensive care unit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 years or older
- Presence of at least one medical device placed for diagnostic or therapeutic purposes.
- No existing medical device-related pressure injury (MDRPI) at the time of study enrollment.
- Expected length of stay in the intensive care unit of at least 24 hours.
- Willingness to participate in the study and provision of written informed consent by the participant or their legal representative.
Key exclusion criteria (4 listed)
- Presence of only a peripheral intravenous (IV) catheter as a medical device. (Peripheral IV catheters are excluded because they are routinely present in ICU patients and their replacement frequency and treatment-related use may vary rapidly and unpredictably)
- Presence of an existing MDRPI at the time of study enrollment.
- Expected intensive care unit stay of less than 24 hours.
- Refusal to participate, failure to provide informed consent, or withdrawal of consent during the study.
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 |
|---|---|---|
| Control GroupAlso: Routine CareRoutine 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. | Other | Routine Care |
| Care Bundle GroupAlso: AI-Synthesized Nursing Care BundleThe 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. | Other | AI-Synthesized Nursing Care Bundle |
Primary outcome
Incidence of Medical device related pressure injury
Time frame: Up to 14 days after enrollment
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.
1 secondary outcome
Total cost per participant
Time frame: Up to 14 days after enrollment
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 Sep 2026.
- Background: PubMed 38641481Neill S, Martin D. Nursing care bundles in the prevention of medical device related pressure ulcers: An integrative review. J Tissue Viability. 2024 Aug;33(3):376-386. doi: 10.1016/j.jtv.2024.04.003. Epub 2024 Apr 10.
- Background: PubMed 39155379Zhang N, Li Y, Li X, Li F, Jin Z, Li T, Ma J. Incidence of medical device-related pressure injuries: a meta-analysis. Eur J Med Res. 2024 Aug 19;29(1):425. doi: 10.1186/s40001-024-01986-2.
- Individual participant dataSharing planned: 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.
Related trials for Medical Device Related Pressure Ulcer (MDRPU)
Not yet recruiting
Evidence-Based Nursing to Reduce Adverse Events Regarding Ventilator Associated Pneumonia, Pressure Injuries and Central Line Bloodstream Infection in Intensive Care Unit in Bangladesh
Ventilator Acquired Pneumonia, Central Line Associated Blood Stream Infections (CLABSI)
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.
Ayişe Karadağ, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care Bundle Group in people with Medical Device Related Pressure Ulcer (MDRPU) and Pressure Injury, run by Koç University 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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 17 Sep 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?
Contact Aleyna Uçanbelen, PhD Candidate (+905317353003, aucanbelen23@ku.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Medical device related pressure injury (time frame: Up to 14 days after enrollment). 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 NCT07789613, which also lists 2 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 Sep 2026.