Medical Device Site ErosionMDRPINCT06513936
Nursing Interventions on Prevention Medical Device Related Pressure Injury (MDRPI)
A study testing The skin care Bundle and Routine care in people with Medical Device Site Erosion, run by Damanhour University at 1 site in Egypt.
Trial summary
This study aims to assess the effect of implementing nursing interventions on preventing medical device related pressure injury in critically ill patients. Research hypothesis: Critically ill patients who experienced nursing interventions have a significantly lower risk of developing medical device related pressure… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Medical Device Site Erosion
- What is being tested?
- The skin care Bundle and Routine care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Newly admitted patient to ICU with no skin break down
Who cannot join
- Patients with skin break down will excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Implementing Nursing Interventions on Prevention Medical Device Related Pressure Injury in Critically Ill Patients
This study aims to assess the effect of implementing nursing interventions on preventing medical device related pressure injury in critically ill patients.
Research hypothesis:
Critically ill patients who experienced nursing interventions have a significantly lower risk of developing medical device related pressure injury than those who do not.
Read the detailed description
This study aims to assess the effect of implementing nursing interventions on preventing medical device-related pressure injuries in critically ill patients.
Operational definition: The selected nursing interventions refer to the skin care Bundle, which includes eight key components.
Design and methods:
Research design: A parallel randomized control trial research design will be conducted.
Setting: The current study was conducted in intensive care units (ICUs) at Main Alexandria University Hospital in Egypt. Those units received patients with critical illness and immobility who were independent on nursing care to meet their basic needs.
Subjects:
This study will include a convenience sample of 120 critically ill patients who require ventilatory support. Adult patients (age ≥18 years) in the ICU who were more than 24 hours after admission were eligible for inclusion. The exclusion criteria for the patients were as follows: (i) patients who had skin diseases such as systemic lupus erythematosus and burns that may have influenced the judgment of medical device related pressure injury; (ii) patients who were not in the ICU for treatment or examination during the investigation; and (iii) patients with medical device related pressure injury before they were admitted to the ICU
Tools of the study:
Three parts make up Tool one, which evaluates general patient data. Part one: Patients' characteristics such as age, sex, admission cause, history, length of stay, APACHE II score, body mass index, no of invasive devices used and mechanical ventilator duration.
Part two: Patient clinical assessment includes vital signs such as oxygen saturation, albumin, type of nutritional support, level of consciousness, capillary refill, and edema grade.
Part three: skin assessment. The Braden Scale for Predicting Pressure Sore Risk is defined as a pressure ulcer development risk prediction score that is based on a patient's sensory perception, skin moisture levels, activity, mobility, nutrition, friction, and shearing. Scores range from 6 to 23. A score of 15-18 indicates that the patient is at mild risk for developing a pressure ulcer; a score of 13-14 indicates moderate risk; a score of 10-12 indicates high risk; and a score of equal to or less than 9 indicates severe risk.
Two medical devices are used and consist of three parts.
Part one: ICU medical device assessment: this part is used to assess the number of non-invasive and invasive devices and whether they are needed or not. Each site will be assessed for the Pressure Ulcer Staging Form based on classification of Pressure Ulcer Grading:
Grade 1: non-blanchable erythema of intact skin. Discoloration of the skin, warmth, oedema, induration, or hardness may also be used as indicators, particularly in individuals with darker skin.
Grade 2: Partial thickness skin loss involving the epidermis, dermis, or both. The superficial ulcer presents clinically as an abrasion or blister.
Grade 3: Full-thickness skin loss involving damage to or necrosis of subcutaneous tissue that may extend down to, but not through, underlying fascia.
Grade 4: Extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures with or without full thickness skin loss Two medical devices are used and consist of three parts.
Method:
Ethical approval will be obtained from the university committee. After an explanation of the study's purpose, hospitals administrative authorities' permission to perform the study was acquired from selected hospitals.
The reliability of the tool was established, and it was accepted. A pilot study was done on 10% of the studied population to assess the accessibility of two tools, and necessary modifications were made.
Data collection phase:
A letter was submitted from the Dean of the Faculty of Nursing, Damanhour University, to the director of intensive care units at the Alexandria main university in Alexandria government hospitals in Egypt.
The validity of the instruments was verified by presenting them to five experts in the field of the study, who revised them. The recommended modifications will be made.
On the first admission day, the researchers assessed all newly admitted mechanically ventilated patients to identify the exclusion criteria. They were assigned equally to controlled and intervention groups.
The patients will be assigned to two equal groups: the control (A) and intervention (B) groups.
Group A received routine nursing care for medical devices.
The intervention group (B) received skin care bundle. It includes eight key components:
Secure devices and protect the skin with dressings in high-risk areas. K: Keep repositioning more frequently than twice daily (if not medically contraindicated); remove the medical device as soon as medically feasible.
Inspect the skin under the device more than twice daily; high-risk patients will require more frequent assessments.
Nutrition and hydration, nutrition deprivation, and insufficient dietary intake are risk factors for medical device-related pressure injuries and impaired wound healing.
Choose the correct size and type of medical device to fit the individual. A. Avoid placing devices over sites of prior or existing pressure injury or assess the patient's risk status.
Report medical device-related pressure injuries correctly and immediately; monitor incidence and prevalence.
Educate staff on the correct use of devices and prevention of skin breakdown (younger and older patients are at high risk); never apply additional pressure when securing a device; and do not position the patient directly on a medical device unless it cannot be avoided.
- Conditions
- Medical Device Site Erosion
- Being tested
- The skin care Bundle, Routine care
- Keywords
- Nursing interventions, Pressure ulcer
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The skin care BundleProcedure or surgery
S- Secure device and protect the skin with dressings K- Keep repositioning more frequently than twice daily Inspect the skin under the device more than twice daily N- Nutrition and hydration C- Choose the correct size and type of medical device A- Avoid placing devices over sites of prior or existing pressure injury R- Report MDRPI correctly and immediately E- Educate staff on the correct use of devices and prevention of skin breakdown
Routine careProcedure or surgery
Routine care delivered in the unit
| Study group | Role | What they receive |
|---|---|---|
| Skin care bundle | Experimental | Patient who received the intervention Receives: Procedure: The skin care Bundle |
| Control group | Placebo comparator | Patient who receive routine intervention Receives: Procedure: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure Ulcer occurrence
Pressure Ulcer Grading based on 6 stages stage. Score 1 refer to the better outcome, while score 6 is the worse outcome
Measured: 7 days
Secondary outcomes (2)
ICU length
until patient discharge
Measured: 30 days
Mechanical ventilator days
How many days on ventilator
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start1 Oct 2024
- Primary completion1 Dec 2025
- Study completion1 Jul 2026
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 Site ErosionStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Two arm groups will be included control group arm (receive standard care) study group arm (receive skin care bundle)
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damanhour University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimmaa Elsayed, Damanhour University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513936
- Sponsor's protocol ID
- Skin care
- Acronym
- MDRPI
- Status last verified
- Aug 2026
- First submitted
- 15 Jul 2024
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pittman J, Gillespie C. Medical Device-Related Pressure Injuries. Crit Care Nurs Clin North Am. 2020 Dec;32(4):533-542. doi: 10.1016/j.cnc.2020.08.004. Epub 2020 Oct 7.
PubMed 33129412de Assis IIC, Estevam Dos Santos J, Valadares Sinicio Abib ML, Furtado Bueno L, de Mendonca Figueiredo Coelho M, Nogueira Cortez D, Teixeira Moraes J. Medical Device-Related Pressure Injury in an Intensive Care Unit: A Cross-Sectional Study. Wound Manag Prev. 2021 Nov;67(11):26-32.
PubMed 35030095
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Implementing Nursing Interventions on Prevention Medical Device Related Pressure Injury in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT06513936
- Acronym / sponsor ID
- MDRPI / Skin care
- Conditions
- Medical Device Site Erosion
- Keywords
- Nursing interventions, Pressure ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Damanhour UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 22 Jul 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.
This study aims to assess the effect of implementing nursing interventions on preventing medical device related pressure injury in critically ill patients.
Research hypothesis:
Critically ill patients who experienced nursing interventions have a significantly lower risk of developing medical device related pressure injury than those who do not.
Detailed description
This study aims to assess the effect of implementing nursing interventions on preventing medical device-related pressure injuries in critically ill patients.
Operational definition: The selected nursing interventions refer to the skin care Bundle, which includes eight key components.
Design and methods:
Research design: A parallel randomized control trial research design will be conducted.
Setting: The current study was conducted in intensive care units (ICUs) at Main Alexandria University Hospital in Egypt. Those units received patients with critical illness and immobility who were independent on nursing care to meet their basic needs.
Subjects:
This study will include a convenience sample of 120 critically ill patients who require ventilatory support. Adult patients (age ≥18 years) in the ICU who were more than 24 hours after admission were eligible for inclusion. The exclusion criteria for the patients were as follows: (i) patients who had skin diseases such as systemic lupus erythematosus and burns that may have influenced the judgment of medical device related pressure injury; (ii) patients who were not in the ICU for treatment or examination during the investigation; and (iii) patients with medical device related pressure injury before they were admitted to the ICU
Tools of the study:
Three parts make up Tool one, which evaluates general patient data. Part one: Patients' characteristics such as age, sex, admission cause, history, length of stay, APACHE II score, body mass index, no of invasive devices used and mechanical ventilator duration.
Part two: Patient clinical assessment includes vital signs such as oxygen saturation, albumin, type of nutritional support, level of consciousness, capillary refill, and edema grade.
Part three: skin assessment. The Braden Scale for Predicting Pressure Sore Risk is defined as a pressure ulcer development risk prediction score that is based on a patient's sensory perception, skin moisture levels, activity, mobility, nutrition, friction, and shearing. Scores range from 6 to 23. A score of 15-18 indicates that the patient is at mild risk for developing a pressure ulcer; a score of 13-14 indicates moderate risk; a score of 10-12 indicates high risk; and a score of equal to or less than 9 indicates severe risk.
Two medical devices are used and consist of three parts.
Part one: ICU medical device assessment: this part is used to assess the number of non-invasive and invasive devices and whether they are needed or not. Each site will be assessed for the Pressure Ulcer Staging Form based on classification of Pressure Ulcer Grading:
Grade 1: non-blanchable erythema of intact skin. Discoloration of the skin, warmth, oedema, induration, or hardness may also be used as indicators, particularly in individuals with darker skin.
Grade 2: Partial thickness skin loss involving the epidermis, dermis, or both. The superficial ulcer presents clinically as an abrasion or blister.
Grade 3: Full-thickness skin loss involving damage to or necrosis of subcutaneous tissue that may extend down to, but not through, underlying fascia.
Grade 4: Extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures with or without full thickness skin loss Two medical devices are used and consist of three parts.
Method:
Ethical approval will be obtained from the university committee. After an explanation of the study's purpose, hospitals administrative authorities' permission to perform the study was acquired from selected hospitals.
The reliability of the tool was established, and it was accepted. A pilot study was done on 10% of the studied population to assess the accessibility of two tools, and necessary modifications were made.
Data collection phase:
A letter was submitted from the Dean of the Faculty of Nursing, Damanhour University, to the director of intensive care units at the Alexandria main university in Alexandria government hospitals in Egypt.
The validity of the instruments was verified by presenting them to five experts in the field of the study, who revised them. The recommended modifications will be made.
On the first admission day, the researchers assessed all newly admitted mechanically ventilated patients to identify the exclusion criteria. They were assigned equally to controlled and intervention groups.
The patients will be assigned to two equal groups: the control (A) and intervention (B) groups.
Group A received routine nursing care for medical devices.
The intervention group (B) received skin care bundle. It includes eight key components:
Secure devices and protect the skin with dressings in high-risk areas. K: Keep repositioning more frequently than twice daily (if not medically contraindicated); remove the medical device as soon as medically feasible.
Inspect the skin under the device more than twice daily; high-risk patients will require more frequent assessments.
Nutrition and hydration, nutrition deprivation, and insufficient dietary intake are risk factors for medical device-related pressure injuries and impaired wound healing.
Choose the correct size and type of medical device to fit the individual. A. Avoid placing devices over sites of prior or existing pressure injury or assess the patient's risk status.
Report medical device-related pressure injuries correctly and immediately; monitor incidence and prevalence.
Educate staff on the correct use of devices and prevention of skin breakdown (younger and older patients are at high risk); never apply additional pressure when securing a device; and do not position the patient directly on a medical device unless it cannot be avoided.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two arm groups will be included control group arm (receive standard care) study group arm (receive skin care bundle)
| Arm | Type | Receives |
|---|---|---|
| Skin care bundle | Experimental | Procedure: The skin care BundlePatient who received the intervention |
| Control group | Placebo comparator | Procedure: Routine carePatient who receive routine intervention |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Newly admitted patient to ICU with no skin break down
Key exclusion criteria (1 listed)
- Patients with skin break down will excluded from 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 |
|---|---|---|
| The skin care BundleS- Secure device and protect the skin with dressings K- Keep repositioning more frequently than twice daily Inspect the skin under the device more than twice daily N- Nutrition and hydration C- Choose the correct size and type of medical device A- Avoid placing devices over sites of prior or existing pressure injury R- Report MDRPI correctly and immediately E- Educate staff on the correct use of devices and prevention of skin breakdown | Procedure or surgery | Skin care bundle |
| Routine careRoutine care delivered in the unit | Procedure or surgery | Control group |
Primary outcome
Pressure Ulcer occurrence
Time frame: 7 days
Pressure Ulcer Grading based on 6 stages stage. Score 1 refer to the better outcome, while score 6 is the worse outcome
2 secondary outcomes
ICU length
Time frame: 30 days
Mechanical ventilator days
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Background: PubMed 33129412Pittman J, Gillespie C. Medical Device-Related Pressure Injuries. Crit Care Nurs Clin North Am. 2020 Dec;32(4):533-542. doi: 10.1016/j.cnc.2020.08.004. Epub 2020 Oct 7.
- Background: PubMed 35030095de Assis IIC, Estevam Dos Santos J, Valadares Sinicio Abib ML, Furtado Bueno L, de Mendonca Figueiredo Coelho M, Nogueira Cortez D, Teixeira Moraes J. Medical Device-Related Pressure Injury in an Intensive Care Unit: A Cross-Sectional Study. Wound Manag Prev. 2021 Nov;67(11):26-32.
- Individual participant dataSharing planned: Undecided
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. This study is not recruiting at the moment.
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 The skin care Bundle and Routine care in people with Medical Device Site Erosion, run by Damanhour University at 1 site in Egypt.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 26 Aug 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pressure Ulcer occurrence (time frame: 7 days). 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 NCT06513936, 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 26 Aug 2026.