Oral Mucosal Membrane Pressure InjuryNCT07775027
EFFECT OF A NURSING CARE BUNDLE ON MEDICAL DEVICE-RELATED ORAL MUCOSAL MEMBRANE PRESSURE INJURIES IN INTENSIVE CARE PATIENTS
A study testing Evidence-Based Oral Care Bundle in people with Oral Mucosal Membrane Pressure Injury, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
This research was designed as a randomized controlled experimental study to evaluate the effect of a care package, created by combining evidence-based nursing interventions, on the development of oral mucosal membrane pressure injury in mechanically ventilated and intubated patients in tertiary intensive care units. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Mucosal Membrane Pressure Injury
- What is being tested?
- Evidence-Based Oral Care Bundle
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2026to 30 Nov 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receiving inpatient treatment in a tertiary intensive care unit Orotracheally intubated and receiving invasive mechanical ventilation support Aged 18 years or older Informed consent provided by the patient's legal representative
Who cannot join
- Aged under 18 years History of malignant disease (cancer) History of known oral mucosal disease Refusal of informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Eskişehir Yunus Emre State Hospital
Eskişehir, Zzz_not_valid_zzz, 26100
serap Yılmaztürk, Nurse, 05057104770, serapotar@gmail.com
About this study
This research was designed as a randomized controlled experimental study to evaluate the effect of a care package, created by combining evidence-based nursing interventions, on the development of oral mucosal membrane pressure injury in mechanically ventilated and intubated patients in tertiary intensive care units. The study aimed to determine the role of the standardized care package in reducing the development of oral mucosal damage compared to routine care practices.
Read the detailed description
The EPUAP (European Pressure Ulcer Advisory Panel) defines pressure ulcers as "Pressure injuries are localized injuries to the skin and/or underlying tissue, usually over a bony prominence, resulting from sustained pressure." The National Pressure Injury Advisory Panel (NPIAP) in the United States defines medical device-related pressure injuries as "results in the use of devices designed and applied for diagnostic or therapeutic purposes." In 2019, the term 'medical device-related pressure injury' (MDRPI) was changed to 'device-related pressure injury' (DRPI), a concept that defines the cause of the injury. Mucosal membrane pressure injury (MMPI) is a type of Medical Device-Related Pressure Injury. Mucosal membrane pressure injury (MMPI) is defined by the NPIAP as localized tissue damage occurring in mucous membranes in association with the use of a medical device (endotracheal tube, nasogastric tube, urinary catheter, etc.). Biomechanically, these injuries; MMPI develops as a result of continuous vertical pressure, friction, and shear forces applied to the mucosa by medical devices, leading to tissue ischemia and hypoxia (Amrani and Gefen, 2020). Oral endotracheal tube-associated mucosal pressure injury (OETMMPI) refers to pressure injuries (PI) occurring in the lips or oral mucosa due to pressure from endotracheal tube fixators (Yiğitoğlu \& Aydoğan, 2023).
Especially in intensive care units (ICUs), dependence on life-saving medical devices and the loss of consciousness or mobility of patients expose them to a very high risk of MMPI (Cuddigan et al., 2022). Current comprehensive reviews in the literature show that the incidence of MMPI in critically ill patients can range from 0.83% to 88.2%, and the prevalence from 0.16% to 55.6%, with the most frequently affected area being the oral mucosa (Chen et al., 2024). A 5-year retrospective analysis reported that while the overall hospital rate for device-related mucosal injury was 0.1%, this rate was approximately 70 times higher (2.4%) in ICU patients, with 70.3% of cases originating from endotracheal tubes (Fulbrook et al., 2023). According to a 2025 study by Chen et al., approximately half of orotracheal endotracheal tube-related mucosal pressure injuries (OETMMPI) developed on the second day of intubation, with an average occurrence time of the fourth day. Therefore, it was emphasized that ICU patients expected to remain intubated for more than four days should be particularly protected. In conclusion, oral mucosal membrane pressure injuries, which occur with a high incidence in intubated ICU patients, are a significant problem that increases patient pain, raises the risk of infection (e.g., ventilator-associated pneumonia), and leads to worsening of the clinical picture (Chen et al., 2024). To prevent these injuries, early identification of risk factors, regular oral mucosal assessments at the beginning of each shift, and integration of evidence-based nursing care packages into clinical routine are critical requirements (Chen et al., 2024; Özdemir and Kavaklı, 2025). According to a 2025 study by Gao et al., intensive care nurses' knowledge and behavior regarding the OETMMPI were at a moderate level and needed improvement. For all these reasons, preventing these injuries is a crucial aspect of intensive care nursing. The study is planned to be conducted in two parallel tertiary intensive care units at Eskişehir Yunus Emre State Hospital and is a randomized experimental study with a control group. Routine care practices will be continued in one intensive care unit (control group), while an evidence-based standardized care package will be applied in the other (intervention group). The research will not involve any invasive procedures; oral care will be performed. The intervention applied is the standardization of existing nursing care with evidence-based practices. Scale-based assessments will be conducted. Data will be analyzed using appropriate statistical methods. The study sample will consist of mechanically ventilated, intubated patients over 18 years of age with no known oral mucosal disease or cancer history.
- Conditions
- Oral Mucosal Membrane Pressure Injury
- Being tested
- Evidence-Based Oral Care Bundle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evidence-Based Oral Care BundleOther
A standardized evidence-based nursing oral care bundle will be implemented for mechanically ventilated, orotracheally intubated adult intensive care patients. The bundle will include standardized oral care practices developed from current evidence and expert review, with the aim of reducing the incidence and delaying the development of oral mucosal membrane pressure injuries associated with endotracheal tube use.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Experimental. Mechanically ventilated adult patients will receive a standardized evidence-based oral care bundle developed to prevent oral mucosal membrane pressure injuries associated with orotracheal endotracheal tubes. Receives: Other: Evidence-Based Oral Care Bundle |
| Control Group | No intervention | Active Comparator. Patients will receive the routine oral care practices currently provided in the intensive care unit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Oral Mucosal Membrane Pressure Injury
Incidence of oral mucosal membrane pressure injury associated with orotracheal endotracheal tube use, assessed using the Modified Reaper Oral Mucosal Pressure Injury Scale (M-ROMPIS).
Measured: From enrollment until completion of the 7-day follow-up period
Secondary outcomes (1)
Severity of Oral Mucosal Membrane Pressure Injury
Severity of Oral Mucosal Membrane Pressure Injury - Severity assessed using M-ROMPIS during the 7-day follow-up period.
Measured: 7-day follow-up period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral Mucosal Membrane Pressure InjuryStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- 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
- Model description
- Participants will be assigned to two parallel groups. One intensive care unit will receive a standardized evidence-based oral care bundle, while the other intensive care unit will continue routine oral care practices.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, özlem doğu, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07775027
- Sponsor's protocol ID
- E-43012747-050.04-590393-418
- Status last verified
- Aug 2026
- First submitted
- 15 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Li Q, Shi X, Lu X, Wang L, Zhu Y, Chen B, Sun H, Lan M. Incidence of, and factors associated with, oral mucous membrane medical device-related pressure injury in critically ill patients with orotracheal intubation: a prospective cohort study. BMJ Open. 2025 Jun 17;15(6):e098114. doi: 10.1136/bmjopen-2024-098114.
PubMed 40527564
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF A NURSING CARE BUNDLE ON MEDICAL DEVICE-RELATED ORAL MUCOSAL MEMBRANE PRESSURE INJURIES IN INTENSIVE CARE PATIENTS
- ClinicalTrials.gov ID
- NCT07775027
- Acronym / sponsor ID
- E-43012747-050.04-590393-418
- Conditions
- Oral Mucosal Membrane Pressure Injury
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 19 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.
This research was designed as a randomized controlled experimental study to evaluate the effect of a care package, created by combining evidence-based nursing interventions, on the development of oral mucosal membrane pressure injury in mechanically ventilated and intubated patients in tertiary intensive care units. The study aimed to determine the role of the standardized care package in reducing the development of oral mucosal damage compared to routine care practices.
Detailed description
The EPUAP (European Pressure Ulcer Advisory Panel) defines pressure ulcers as "Pressure injuries are localized injuries to the skin and/or underlying tissue, usually over a bony prominence, resulting from sustained pressure." The National Pressure Injury Advisory Panel (NPIAP) in the United States defines medical device-related pressure injuries as "results in the use of devices designed and applied for diagnostic or therapeutic purposes." In 2019, the term 'medical device-related pressure injury' (MDRPI) was changed to 'device-related pressure injury' (DRPI), a concept that defines the cause of the injury. Mucosal membrane pressure injury (MMPI) is a type of Medical Device-Related Pressure Injury. Mucosal membrane pressure injury (MMPI) is defined by the NPIAP as localized tissue damage occurring in mucous membranes in association with the use of a medical device (endotracheal tube, nasogastric tube, urinary catheter, etc.). Biomechanically, these injuries; MMPI develops as a result of continuous vertical pressure, friction, and shear forces applied to the mucosa by medical devices, leading to tissue ischemia and hypoxia (Amrani and Gefen, 2020). Oral endotracheal tube-associated mucosal pressure injury (OETMMPI) refers to pressure injuries (PI) occurring in the lips or oral mucosa due to pressure from endotracheal tube fixators (Yiğitoğlu \& Aydoğan, 2023).
Especially in intensive care units (ICUs), dependence on life-saving medical devices and the loss of consciousness or mobility of patients expose them to a very high risk of MMPI (Cuddigan et al., 2022). Current comprehensive reviews in the literature show that the incidence of MMPI in critically ill patients can range from 0.83% to 88.2%, and the prevalence from 0.16% to 55.6%, with the most frequently affected area being the oral mucosa (Chen et al., 2024). A 5-year retrospective analysis reported that while the overall hospital rate for device-related mucosal injury was 0.1%, this rate was approximately 70 times higher (2.4%) in ICU patients, with 70.3% of cases originating from endotracheal tubes (Fulbrook et al., 2023). According to a 2025 study by Chen et al., approximately half of orotracheal endotracheal tube-related mucosal pressure injuries (OETMMPI) developed on the second day of intubation, with an average occurrence time of the fourth day. Therefore, it was emphasized that ICU patients expected to remain intubated for more than four days should be particularly protected. In conclusion, oral mucosal membrane pressure injuries, which occur with a high incidence in intubated ICU patients, are a significant problem that increases patient pain, raises the risk of infection (e.g., ventilator-associated pneumonia), and leads to worsening of the clinical picture (Chen et al., 2024). To prevent these injuries, early identification of risk factors, regular oral mucosal assessments at the beginning of each shift, and integration of evidence-based nursing care packages into clinical routine are critical requirements (Chen et al., 2024; Özdemir and Kavaklı, 2025). According to a 2025 study by Gao et al., intensive care nurses' knowledge and behavior regarding the OETMMPI were at a moderate level and needed improvement. For all these reasons, preventing these injuries is a crucial aspect of intensive care nursing. The study is planned to be conducted in two parallel tertiary intensive care units at Eskişehir Yunus Emre State Hospital and is a randomized experimental study with a control group. Routine care practices will be continued in one intensive care unit (control group), while an evidence-based standardized care package will be applied in the other (intervention group). The research will not involve any invasive procedures; oral care will be performed. The intervention applied is the standardization of existing nursing care with evidence-based practices. Scale-based assessments will be conducted. Data will be analyzed using appropriate statistical methods. The study sample will consist of mechanically ventilated, intubated patients over 18 years of age with no known oral mucosal disease or cancer history.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be assigned to two parallel groups. One intensive care unit will receive a standardized evidence-based oral care bundle, while the other intensive care unit will continue routine oral care practices.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Evidence-Based Oral Care BundleExperimental. Mechanically ventilated adult patients will receive a standardized evidence-based oral care bundle developed to prevent oral mucosal membrane pressure injuries associated with orotracheal endotracheal tubes. |
| Control Group | No intervention | –Active Comparator. Patients will receive the routine oral care practices 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 (1 listed)
- Receiving inpatient treatment in a tertiary intensive care unit Orotracheally intubated and receiving invasive mechanical ventilation support Aged 18 years or older Informed consent provided by the patient's legal representative
Key exclusion criteria (1 listed)
- Aged under 18 years History of malignant disease (cancer) History of known oral mucosal disease Refusal of informed consent
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 |
|---|---|---|
| Evidence-Based Oral Care BundleA standardized evidence-based nursing oral care bundle will be implemented for mechanically ventilated, orotracheally intubated adult intensive care patients. The bundle will include standardized oral care practices developed from current evidence and expert review, with the aim of reducing the incidence and delaying the development of oral mucosal membrane pressure injuries associated with endotracheal tube use. | Other | Intervention Group |
Primary outcome
Incidence of Oral Mucosal Membrane Pressure Injury
Time frame: From enrollment until completion of the 7-day follow-up period
Incidence of oral mucosal membrane pressure injury associated with orotracheal endotracheal tube use, assessed using the Modified Reaper Oral Mucosal Pressure Injury Scale (M-ROMPIS).
1 secondary outcome
Severity of Oral Mucosal Membrane Pressure Injury
Time frame: 7-day follow-up period.
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 19 Aug 2026.
- Background: PubMed 40527564Li Q, Shi X, Lu X, Wang L, Zhu Y, Chen B, Sun H, Lan M. Incidence of, and factors associated with, oral mucous membrane medical device-related pressure injury in critically ill patients with orotracheal intubation: a prospective cohort study. BMJ Open. 2025 Jun 17;15(6):e098114. doi: 10.1136/bmjopen-2024-098114.
- Individual participant dataSharing planned: Undecided
Related trials for Oral Mucosal Membrane Pressure Injury
Not yet recruiting
The Effect of Changes in the Frequency of Endotracheal Tube Repositioning in Intensive Care Units on the Prevention of Oral Mucosal Pressure Injuries
Mucosal Wound, Mucosal Erosion
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evidence-Based Oral Care Bundle in people with Oral Mucosal Membrane Pressure Injury, run by Sakarya 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 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: opening soon, as of the sponsor's last update on 19 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 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 ÖZLEM DOĞU, Assoc.Prof. (05056792063, ozlemdogu@sakarya.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Oral Mucosal Membrane Pressure Injury (time frame: From enrollment until completion of the 7-day follow-up period). 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 NCT07775027, which also lists 1 linked publication.
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 19 Aug 2026.