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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Egypt1 site
  • Faculty of nursing

    Damanhūr

Other trials in Egypt

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.

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 groups in NCT06513936
Study groupRoleWhat they receive
Skin care bundleExperimentalPatient who received the intervention
Receives: Procedure: The skin care Bundle
Control groupPlacebo comparatorPatient 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.

  1. 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)
  1. ICU length

    until patient discharge

    Measured: 30 days

  2. 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.

  1. First posted22 Jul 2024
  2. Study start1 Oct 2024
  3. Primary completion1 Dec 2025
  4. Study completion1 Jul 2026

Resources

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)
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 33129412
  • de 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

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.

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