Pressure Injury PreventionNCT07608484
The Effect of Silicone Foam Dressing and Repositioning on the Prevention of Endotracheal Tube-related Pressure Injuries
A study testing Use of silicone foam dressing and repositioning every 8 hours and Repositioning every 8 hours in people with Pressure Injury Prevention, run by Hacettepe University.
Trial summary
The endotracheal tube is one of the medical devices most associated with pressure injuries related to medical devices. This study aims to evaluate the effectiveness of applying a silicone foam dressing over the endotracheal tube and repositioning the endotracheal tube in preventing endotracheal tube-related pressure… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Injury Prevention
- What is being tested?
- Use of silicone foam dressing and repositioning every 8 hours and Repositioning every 8 hours
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 30 Aug 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
- Aged 18 years or older
- Patients admitted to the General Intensive Care Unit and receiving mechanical ventilation support
- Absence of pressure injuries, other lesions, or anomalies on the inner and outer surfaces of the lips and at the oral commissures prior to intubation
- Absence of congenital anomalies that could interfere with the assessment of pressure injuries on the inner and outer surfaces of the lips and at the oral commissures
Who cannot join
- Receiving mechanical ventilation support initiated prior to admission to the intensive care unit
- Undergoing nasotracheal intubation
- History of any intraoral surgical procedure
- Presence of a contraindication to repositioning of the endotracheal tube
- More than one hour having elapsed since intubation (for Group 1)
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: The Effect of Silicone Foam Dressing and Repositioning on the Prevention of Endotracheal Tube-related Pressure Injuries: A Randomized Comparative Study
The endotracheal tube is one of the medical devices most associated with pressure injuries related to medical devices. This study aims to evaluate the effectiveness of applying a silicone foam dressing over the endotracheal tube and repositioning the endotracheal tube in preventing endotracheal tube-related pressure injuries in patients receiving mechanical ventilation support.
Read the detailed description
This study will be conducted as a prospective, parallel, three-group (1:1:1), randomized comparative trial. Data will be collected using the following instruments: the "Patient Descriptive Information Form," the "Braden Pressure Injury Risk Assessment Scale" to assess the risk of pressure injury development, the "M-ROMPIS" for staging endotracheal tube-related pressure injuries, and the "Endotracheal Tube-Related Pressure Injury Assessment Form" for monitoring the development of endotracheal tube-related pressure injuries. Data analysis will use both parametric tests (Independent Samples t-test, ANOVA) or non-parametric tests (Mann-Whitney U test, Kruskal-Wallis H test) based on the data distribution for comparisons involving two groups or multiple groups. The Chi-square test will be used for categorical variables. Logistic Regression Analysis will be performed to determine the effects of pressure injury development time and continuous variables obtained during patient follow-up on the development or non-development of pressure injuries.
- Conditions
- Pressure Injury Prevention
- Being tested
- Use of silicone foam dressing and repositioning every 8 hours, Repositioning every 8 hours
- Keywords
- Pressure injury, Intensive care unit, Endotracheal tube, Prevention
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of silicone foam dressing and repositioning every 8 hoursOther
Patients assigned to this group will receive a silicone foam dressing applied over the endotracheal tube, with repositioning performed every 8 hours. As the silicone foam wound dressing, AQUACEL™ Foam, a sterile, waterproof dressing consisting of a polyurethane outer film layer and a multilayer absorbent pad with silicone adhesive borders, will be used.
Repositioning every 8 hoursOther
In patients assigned to this group, the initial repositioning following intubation and the first assessment of the lips, oral cavity, and perioral skin and mucosa will be performed 8 hours after intubation. If the endotracheal tube (ETT) is positioned at the right or left corner of the mouth, it will be repositioned to the midline; if it is positioned at the midline, it will be repositioned to either the right or left corner of the mouth. Following the initial repositioning, subsequent repositioning procedures will be performed every 8 hours.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Use of silicone foam dressing and repositioning every 8 hours Receives: Other: Use of silicone foam dressing and repositioning every 8 hours |
| Group 2 | Active comparator | Repositioning every 8 hours Receives: Other: Repositioning every 8 hours |
| Group 3 | No intervention | Standard care (Control Group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of whether a ETT related oral mucosa pressure injury develop
Endotracheal Tube-Related Pressure Injury Assessment Form
Measured: From intubation until the end of follow-up, up to 14 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure Injury PreventionStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cansu CAMBAZ, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07608484
- Sponsor's protocol ID
- E2-26-14520
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Silicone Foam Dressing and Repositioning on the Prevention of Endotracheal Tube-related Pressure Injuries: A Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT07608484
- Acronym / sponsor ID
- E2-26-14520
- Conditions
- Pressure Injury Prevention
- Keywords
- Pressure injury, Intensive care unit, Endotracheal tube, Prevention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 27 May 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.
The endotracheal tube is one of the medical devices most associated with pressure injuries related to medical devices. This study aims to evaluate the effectiveness of applying a silicone foam dressing over the endotracheal tube and repositioning the endotracheal tube in preventing endotracheal tube-related pressure injuries in patients receiving mechanical ventilation support.
Detailed description
This study will be conducted as a prospective, parallel, three-group (1:1:1), randomized comparative trial. Data will be collected using the following instruments: the "Patient Descriptive Information Form," the "Braden Pressure Injury Risk Assessment Scale" to assess the risk of pressure injury development, the "M-ROMPIS" for staging endotracheal tube-related pressure injuries, and the "Endotracheal Tube-Related Pressure Injury Assessment Form" for monitoring the development of endotracheal tube-related pressure injuries. Data analysis will use both parametric tests (Independent Samples t-test, ANOVA) or non-parametric tests (Mann-Whitney U test, Kruskal-Wallis H test) based on the data distribution for comparisons involving two groups or multiple groups. The Chi-square test will be used for categorical variables. Logistic Regression Analysis will be performed to determine the effects of pressure injury development time and continuous variables obtained during patient follow-up on the development or non-development of pressure injuries.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Use of silicone foam dressing and repositioning every 8 hoursUse of silicone foam dressing and repositioning every 8 hours |
| Group 2 | Active comparator | Other: Repositioning every 8 hoursRepositioning every 8 hours |
| Group 3 | No intervention | –Standard care (Control Group) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 years or older
- Patients admitted to the General Intensive Care Unit and receiving mechanical ventilation support
- Absence of pressure injuries, other lesions, or anomalies on the inner and outer surfaces of the lips and at the oral commissures prior to intubation
- Absence of congenital anomalies that could interfere with the assessment of pressure injuries on the inner and outer surfaces of the lips and at the oral commissures
Key exclusion criteria (5 listed)
- Receiving mechanical ventilation support initiated prior to admission to the intensive care unit
- Undergoing nasotracheal intubation
- History of any intraoral surgical procedure
- Presence of a contraindication to repositioning of the endotracheal tube
- More than one hour having elapsed since intubation (for Group 1)
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 |
|---|---|---|
| Use of silicone foam dressing and repositioning every 8 hoursPatients assigned to this group will receive a silicone foam dressing applied over the endotracheal tube, with repositioning performed every 8 hours. As the silicone foam wound dressing, AQUACEL™ Foam, a sterile, waterproof dressing consisting of a polyurethane outer film layer and a multilayer absorbent pad with silicone adhesive borders, will be used. | Other | Group 1 |
| Repositioning every 8 hoursIn patients assigned to this group, the initial repositioning following intubation and the first assessment of the lips, oral cavity, and perioral skin and mucosa will be performed 8 hours after intubation. If the endotracheal tube (ETT) is positioned at the right or left corner of the mouth, it will be repositioned to the midline; if it is positioned at the midline, it will be repositioned to either the right or left corner of the mouth. Following the initial repositioning, subsequent repositioning procedures will be performed every 8 hours. | Other | Group 2 |
Primary outcome
Assessment of whether a ETT related oral mucosa pressure injury develop
Time frame: From intubation until the end of follow-up, up to 14 days.
Endotracheal Tube-Related Pressure Injury Assessment Form
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 2 Jun 2026.
- Individual participant dataSharing planned: No
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Evaluation of Commercially Available Heel Pads for the Prevention of Pressure Ulcers: An Observational Study of Incidence and Usability in Adult Surgical Patients.
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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 Use of silicone foam dressing and repositioning every 8 hours and Repositioning every 8 hours in people with Pressure Injury Prevention, run by Hacettepe University.
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 4 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 2 Jun 2026. 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 Cansu CAMBAZ (+9 0312 305 15 80, cansuyildizoglu65@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of whether a ETT related oral mucosa pressure injury develop (time frame: From intubation until the end of follow-up, up to 14 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2026.