Medical Device Site InjuryNCT06563830
Prevent Medical Device-Related Pressure Injury
A study testing educational application in people with Medical Device Site Injury and Pressure Injury, run by Tepecik Training and Research Hospital.
Trial summary
Medical Device-Related Pressure Injury (MDRPI) is a localized skin and/or subcutaneous tissue injury that occurs due to the pressure exerted by devices used for diagnostic or therapeutic purposes, taking the form of the medical device used. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medical Device Site Injury, Pressure Injury
- What is being tested?
- educational application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 30 Dec 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
- Criteria for inclusion of nurses:
- -Volunteer
- Criteria for inclusion of patients:
- Volunteer
- Who has been hospitalized in intensive care for at least 24 hours
- Do not have a pressure injury during admission to intensive care
Who cannot join
- -Do not volunteer
- Criteria for inclusion of patients:
- Do not volunteer
- Was admitted to intensive care in less than 24 hours and transferred
- Patients with pressure injuries during admission to intensive care
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Training Applied to Nurses Prevent Medical Device-Related Pressure Injury
Medical Device-Related Pressure Injury (MDRPI) is a localized skin and/or subcutaneous tissue injury that occurs due to the pressure exerted by devices used for diagnostic or therapeutic purposes, taking the form of the medical device used. Medical device-related pressure injuries are an important adverse event with a high incidence and prevalence both in our country and in the world, accounting for more than 30% of hospital-related injuries. Medical device-related pressure injury significantly affects the quality of life of patients, but also negatively affects the cost of care for both the patient and providers. Although the most important task in preventing medical device-related pressure injuries falls on nurses, it is quite noticeable that nurses' knowledge levels of MDRPI are low in the studies conducted. MDRPI is an important issue that is ignored in nursing education and work areas in our country. In order to prevent pressure injuries associated with medical devices, it is necessary to invest more in early detection of MDRPI and improving the quality of care, studies including MDRPI risk assessment and reporting strategies are needed. In the project to be carried out in this context, it is aimed to evaluate the impact of training applied to nurses to prevent MDRPI.
Read the detailed description
Medical Device-Related Pressure Injury account for more than 30% of hospital-related injuries and their incidence has been increasing steadily in recent years. According to the meta-analysis studies (n:126.150 ) the pooled incidence of MDRPI was found to be 12% (95% Cl 8-18) and the pooled prevalence of MDRPIwas found to be 10% (95% Cl 6-16). As can be seen, MDRPI is an important adverse event with a high incidence and prevalence in the world. Despite this, it is known that the MDRPI risk assessment and reporting system is used only in developed countries such as the United Kingdom, the USA and Canada on a limited basis. Medical device-related pressure injury significantly affects the quality of life of patients, but also negatively affects the cost of care for both the patient and providers. Although the incidence rate of MDRPI is high, the fact that nurses have a low level of MDRPI knowledge draws attention to the importance that should be shown to this issue. In the studies conducted, it is emphasized that in order to prevent MDRPI, more investments should be made in early detection of MDRPI and improvement of the quality of care, and studies including MDRPI risk assessment and reporting strategies are needed.
MDRPI is an important issue that is ignored in nursing education and work areas. The most important task in preventing The most important task in preventing TCIBI falls on nurses. Because patients who are at risk for the development of MDRPI need to be closely monitored continuously and prevention initiatives are needed. In this context, it is extremely important for nurses to have knowledge about the subject and to have up-to-date and evidence-based information in order to prevent MDRPI. However, when the literature is examined, it is seen that the studies measuring nurses' MDRPI knowledge are limited. In the studies conducted, it was found that nurses' knowledge levels about MDRPI were low falls on nurses. Because patients who are at risk for the development of MDRPI need to be closely monitored continuously and prevention initiatives are needed. In this context, it is extremely important for nurses to have knowledge about the subject and to have up-to-date and evidence-based information in order to prevent MDRPI. However, when the literature is examined, it is seen that the studies measuring nurses' MDRPI knowledge are limited. In the studies conducted, it was found that nurses' knowledge levels about MDRPI were low. Although its prevalence is high, education, risk assessment, reporting, prevention strategies about MDRPI are very inadequate and evidence-based studies are needed.
In this study, it was aimed to evaluate the effect of training applied to nurses to prevent MDRPI The hypotheses of the study:
H1: The MDRPI knowledge level of nurses is low before the training application.
H2: The incidence of MDRPI is high before the training application.
H03: There is no Deciency between the knowledge levels of nurses before and after the training application.
H4: Training application increases the knowledge level of nurses about MDRPI.
H5: Training application reduces the incidence of MDRPI.
H6: As the level of knowledge of MDRPI of nurses increases, the incidence of MDRPI also increases.
- Conditions
- Medical Device Site Injury, Pressure Injury
- Being tested
- educational application
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational applicationOther
The content of the training to be applied to nurses will include: definition of MDRPI, etiology, prevalence and cost, staging, risk factors, nursing initiatives to be implemented to prevent MDRPI.
| Study group | Role | What they receive |
|---|---|---|
| Evaluation of MRRPI knowledge and attitude levels of nurses | Other | Before the training application, the effectiveness of the training application will be evaluated by applying pre-test and training application followed by two patients and intermittent post-test after three months. Receives: Other: educational application |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Incidence of Medical Device-Related Pressure Injury
The incidence of patients hospitalized in intensive care will be determined first in the study. For this purpose, patients will be observed at the same time every day during their stay in intensive care. The researcher will fill out the "MDRPI Daily Follow-up Form" for each patient who meets the inclusion criteria during hospitalization. This form has been created by the researchers in accordance with the literature information. 10 Expert opinions will be submitted before the study is carried out.
Measured: Three months before the training was conducted
The Incidence of Medical Device-Related Pressure Injury
The incidence of patients hospitalized in intensive care will be determined first in the study. For this purpose, patients will be observed at the same time every day during their stay in intensive care. If the resulting injury develops, the "Medical Device-Related Pressure Injury Registration Form" will be used and patient monitoring will be continued for wound monitoring and other injuries. Medical Device-Related Pressure Injury Registration Form: It has been created by the researchers in accordance with the literature information. 10 Expert opinions will be submitted before the study is carried out.
Measured: Three months before the training was conducted
Nurse's Knowledge About Medical Device-Related Pressure Injury
Pre-test application will be made with the "MDRPI Knowledge Scale" to determine the level of knowledge and attitude of nurses related to medical device pressure injury before training. Medical Device-related Pressure Injury Information Scale: The Confirmatory Factor Analysis (CFA) fit indices of the scale consisting of five sub-dimensions with Exploratory Factor Analysis (EFA) were determined as x2= 1.84; RMSEA= 0.05; CFI= 0.91; GFI= 0.92; AGFI= 0.90; RFI= 0.89. In addition, the total Cronbach alpha coefficient of the scale was found to be 0.798 and the test-retest score was 0.94. The lowest score that can be taken from the scale is 0 and the highest score is 25. The increase in the score indicates that the level of knowledge of TCIBY of nurses has increased.
Measured: within three months prior to the implementation of training
Nurse's Attitude About Medical Device-Related Pressure Injury
Pre-test application will be made with "The Attidute Towards Medical Device Related Pressure Injuries" to determine the level of attitude of nurses related to medical device pressure injury before training. Preventing Medical Device-Related Pressure Injury: The Scope Validity Index of the questionnaire was found to be 98.03%, the Cronbach α value was 0.92 and the test-retest score was 0.874. The lowest score that can be obtained is 11, the highest score is 55, and the high score indicates a positive attitude towards the care and prevention of pressure injuries associated with a medical vehicle. 11 to 25 points, indicates a negative attitude towards the care and prevention of medical vehicle-related pressure injuries, a neutral attitude of 26 to 40 points, and a positive attitude of 41 to 55 points.
Measured: within three months prior to the implementation of training
Secondary outcomes (2)
Decrease in the Incidence of Medical Device-Related Pressure Injury
In order to determine the effectiveness of the training applied to nurses, the MDRPI incidence of the patients will be determined after the training and compared with the first trimester incidence. For this purpose, patients will be observed at the same time every day during their stay in intensive care. If the resulting injury develops, the "Medical Device-Related Pressure Injury Registration Form" will be used and patient monitoring will be continued for wound monitoring and other injuries.
Medical Device-Related Pressure Injury Registration Form: It has been created by the researchers in accordance with the literature information. 10 Expert opinions will be submitted before the study is carried out.
Measured: The first three months after the training application
Decrease in the Incidence of Medical Device-Related Pressure Injury
In order to determine the effectiveness of the training applied to nurses, the MDRPI incidence of the patients will be determined after the training and compared with the first trimester incidence. For this purpose, patients will be observed at the same time every day during their stay in intensive care. The researcher will fill out the "Medical Device-Related Pressure Injury Daily Follow-up Form" for each patient who meets the inclusion criteria during hospitalization.
Medical Device-Related Pressure Injury Follow-up Form It has been created by the researchers in accordance with the literature information. 10 Expert opinions will be submitted before the study is carried out.
Measured: The first three months after the training application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start1 Nov 2024 (estimated)
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Medical Device Site InjuryStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- It is planned to conduct the study as a semi-experimental, single-group pre-test-post-test.
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tepecik Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zilan BARAN, Tepecik Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06563830
- Sponsor's protocol ID
- Dokuz Eylul University NURSING
- Status last verified
- Oct 2024
- First submitted
- 8 Aug 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kucukkelepce GE, Karaca T, Ozkan SA. The attitude towards Medical Device-Related Pressure Injuries Questionnaire: a Turkish validity and reliability study. Wound Manag Prev. 2023 Nov;69(4):10-17. doi: 10.25270/wmp.22099.
PubMed 38090951Baran Z, Ozden D. Retrospective investigation of pressure injury in COVID-19 patients followed on invasive mechanical ventilator support. J Tissue Viability. 2024 Feb;33(1):144-149. doi: 10.1016/j.jtv.2023.10.001. Epub 2023 Oct 11.
PubMed 38184472Baran, Z., & Özden, D. (2024). Tıbbi Cihaz İlişkili Basınç Yaralanması Bilgi Ölçeği'nin Türkçe Geçerlik ve Güvenirlik Çalışması. İzmir Katip Çelebi Üniversitesi Sağlık Bilimleri Fakültesi Dergisi, 9(1), 73-80. https://doi.org/10.61399/ikcusbfd.1356400
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Training Applied to Nurses Prevent Medical Device-Related Pressure Injury
- ClinicalTrials.gov ID
- NCT06563830
- Acronym / sponsor ID
- Dokuz Eylul University NURSING
- Conditions
- Medical Device Site Injury, Pressure Injury
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Tepecik Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 21 Aug 2024 (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 Injury (MDRPI) is a localized skin and/or subcutaneous tissue injury that occurs due to the pressure exerted by devices used for diagnostic or therapeutic purposes, taking the form of the medical device used. Medical device-related pressure injuries are an important adverse event with a high incidence and prevalence both in our country and in the world, accounting for more than 30% of hospital-related injuries. Medical device-related pressure injury significantly affects the quality of life of patients, but also negatively affects the cost of care for both the patient and providers. Although the most important task in preventing medical device-related pressure injuries falls on nurses, it is quite noticeable that nurses' knowledge levels of MDRPI are low in the studies conducted. MDRPI is an important issue that is ignored in nursing education and work areas in our country. In order to prevent pressure injuries associated with medical devices, it is necessary to invest more in early detection of MDRPI and improving the quality of care, studies including MDRPI risk assessment and reporting strategies are needed. In the project to be carried out in this context, it is aimed to evaluate the impact of training applied to nurses to prevent MDRPI.
Detailed description
Medical Device-Related Pressure Injury account for more than 30% of hospital-related injuries and their incidence has been increasing steadily in recent years. According to the meta-analysis studies (n:126.150 ) the pooled incidence of MDRPI was found to be 12% (95% Cl 8-18) and the pooled prevalence of MDRPIwas found to be 10% (95% Cl 6-16). As can be seen, MDRPI is an important adverse event with a high incidence and prevalence in the world. Despite this, it is known that the MDRPI risk assessment and reporting system is used only in developed countries such as the United Kingdom, the USA and Canada on a limited basis. Medical device-related pressure injury significantly affects the quality of life of patients, but also negatively affects the cost of care for both the patient and providers. Although the incidence rate of MDRPI is high, the fact that nurses have a low level of MDRPI knowledge draws attention to the importance that should be shown to this issue. In the studies conducted, it is emphasized that in order to prevent MDRPI, more investments should be made in early detection of MDRPI and improvement of the quality of care, and studies including MDRPI risk assessment and reporting strategies are needed.
MDRPI is an important issue that is ignored in nursing education and work areas. The most important task in preventing The most important task in preventing TCIBI falls on nurses. Because patients who are at risk for the development of MDRPI need to be closely monitored continuously and prevention initiatives are needed. In this context, it is extremely important for nurses to have knowledge about the subject and to have up-to-date and evidence-based information in order to prevent MDRPI. However, when the literature is examined, it is seen that the studies measuring nurses' MDRPI knowledge are limited. In the studies conducted, it was found that nurses' knowledge levels about MDRPI were low falls on nurses. Because patients who are at risk for the development of MDRPI need to be closely monitored continuously and prevention initiatives are needed. In this context, it is extremely important for nurses to have knowledge about the subject and to have up-to-date and evidence-based information in order to prevent MDRPI. However, when the literature is examined, it is seen that the studies measuring nurses' MDRPI knowledge are limited. In the studies conducted, it was found that nurses' knowledge levels about MDRPI were low. Although its prevalence is high, education, risk assessment, reporting, prevention strategies about MDRPI are very inadequate and evidence-based studies are needed.
In this study, it was aimed to evaluate the effect of training applied to nurses to prevent MDRPI The hypotheses of the study:
H1: The MDRPI knowledge level of nurses is low before the training application.
H2: The incidence of MDRPI is high before the training application.
H03: There is no Deciency between the knowledge levels of nurses before and after the training application.
H4: Training application increases the knowledge level of nurses about MDRPI.
H5: Training application reduces the incidence of MDRPI.
H6: As the level of knowledge of MDRPI of nurses increases, the incidence of MDRPI also increases.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- It is planned to conduct the study as a semi-experimental, single-group pre-test-post-test.
| Arm | Type | Receives |
|---|---|---|
| Evaluation of MRRPI knowledge and attitude levels of nurses | Other | Other: educational applicationBefore the training application, the effectiveness of the training application will be evaluated by applying pre-test and training application followed by two patients and intermittent post-test after three months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- -Volunteer
- Volunteer
- Who has been hospitalized in intensive care for at least 24 hours
- Do not have a pressure injury during admission to intensive care
Key exclusion criteria (5 listed)
- -Do not volunteer
- Do not volunteer
- Was admitted to intensive care in less than 24 hours and transferred
- Patients with pressure injuries during admission to intensive care
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 |
|---|---|---|
| educational applicationThe content of the training to be applied to nurses will include: definition of MDRPI, etiology, prevalence and cost, staging, risk factors, nursing initiatives to be implemented to prevent MDRPI. | Other | Evaluation of MRRPI knowledge and attitude levels of nurses |
Primary outcome
The Incidence of Medical Device-Related Pressure Injury
Time frame: Three months before the training was conducted
The incidence of patients hospitalized in intensive care will be determined first in the study. For this purpose, patients will be observed at the same time every day during their stay in intensive care. The researcher will fill out the "MDRPI Daily Follow-up Form" for each patient who meets the inclusion criteria during hospitalization. This form has been created by the researchers in accordance with the literature information. 10 Expert opinions will be submitted before the study is carried out.
The Incidence of Medical Device-Related Pressure Injury
Time frame: Three months before the training was conducted
The incidence of patients hospitalized in intensive care will be determined first in the study. For this purpose, patients will be observed at the same time every day during their stay in intensive care. If the resulting injury develops, the "Medical Device-Related Pressure Injury Registration Form" will be used and patient monitoring will be continued for wound monitoring and other injuries. Medical Device-Related Pressure Injury Registration Form: It has been created by the researchers in accordance with the literature information. 10 Expert opinions will be submitted before the study is carried out.
Nurse's Knowledge About Medical Device-Related Pressure Injury
Time frame: within three months prior to the implementation of training
Pre-test application will be made with the "MDRPI Knowledge Scale" to determine the level of knowledge and attitude of nurses related to medical device pressure injury before training. Medical Device-related Pressure Injury Information Scale: The Confirmatory Factor Analysis (CFA) fit indices of the scale consisting of five sub-dimensions with Exploratory Factor Analysis (EFA) were determined as x2= 1.84; RMSEA= 0.05; CFI= 0.91; GFI= 0.92; AGFI= 0.90; RFI= 0.89. In addition, the total Cronbach alpha coefficient of the scale was found to be 0.798 and the test-retest score was 0.94. The lowest score that can be taken from the scale is 0 and the highest score is 25. The increase in the score indicates that the level of knowledge of TCIBY of nurses has increased.
Nurse's Attitude About Medical Device-Related Pressure Injury
Time frame: within three months prior to the implementation of training
Pre-test application will be made with "The Attidute Towards Medical Device Related Pressure Injuries" to determine the level of attitude of nurses related to medical device pressure injury before training. Preventing Medical Device-Related Pressure Injury: The Scope Validity Index of the questionnaire was found to be 98.03%, the Cronbach α value was 0.92 and the test-retest score was 0.874. The lowest score that can be obtained is 11, the highest score is 55, and the high score indicates a positive attitude towards the care and prevention of pressure injuries associated with a medical vehicle. 11 to 25 points, indicates a negative attitude towards the care and prevention of medical vehicle-related pressure injuries, a neutral attitude of 26 to 40 points, and a positive attitude of 41 to 55 points.
2 secondary outcomes
Decrease in the Incidence of Medical Device-Related Pressure Injury
Time frame: The first three months after the training application
Decrease in the Incidence of Medical Device-Related Pressure Injury
Time frame: The first three months after the training application
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 16 Oct 2024.
- Background: PubMed 38090951Kucukkelepce GE, Karaca T, Ozkan SA. The attitude towards Medical Device-Related Pressure Injuries Questionnaire: a Turkish validity and reliability study. Wound Manag Prev. 2023 Nov;69(4):10-17. doi: 10.25270/wmp.22099.
- Results publication: PubMed 38184472Baran Z, Ozden D. Retrospective investigation of pressure injury in COVID-19 patients followed on invasive mechanical ventilator support. J Tissue Viability. 2024 Feb;33(1):144-149. doi: 10.1016/j.jtv.2023.10.001. Epub 2023 Oct 11.
- Results publicationBaran, Z., & Özden, D. (2024). Tıbbi Cihaz İlişkili Basınç Yaralanması Bilgi Ölçeği'nin Türkçe Geçerlik ve Güvenirlik Çalışması. İzmir Katip Çelebi Üniversitesi Sağlık Bilimleri Fakültesi Dergisi, 9(1), 73-80. https://doi.org/10.61399/ikcusbfd.1356400
- Related InfoLink provided by the sponsor.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing educational application in people with Medical Device Site Injury and Pressure Injury, run by Tepecik Training and Research Hospital.
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 6 inclusion and 5 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 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Zilan Baran, PhD (05061378002, zilan.baran@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Incidence of Medical Device-Related Pressure Injury (time frame: Three months before the training was conducted). The study lists 4 primary outcomes in all. 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 NCT06563830, which also lists 3 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 16 Oct 2024.