Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07608484

The Effect of Silicone Foam Dressing and Repositioning on the Prevention of Endotracheal Tube-related Pressure Injuries

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Use of silicone foam dressing and repositioning every 8 hours

Other

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 hours

Other

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.

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Cansu CAMBAZ

CONTACT

[email protected]

+9 0312 305 15 80

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

The Effect of Silicone Foam Dressing and Repositioning on the Prevention of Endotracheal Tube-related Pressure Injuries: A Randomized Comparative Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 27, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.