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

NCT07608484 | Not Yet Recruiting DMC

• 1 other identifier: E2-26-14520
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief 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 injuries in patients receiving mechanical ventilation support.

Conditions

Pressure Injury Prevention

Keywords

Pressure injury; Intensive care unit; Endotracheal tube; Prevention

Outcome Measures

Primary Outcomes (1)

• Assessment of whether a ETT related oral mucosa pressure injury develop

  Endotracheal Tube-Related Pressure Injury Assessment Form

  From intubation until the end of follow-up, up to 14 days.

Study Arms (3)

Group 1

EXPERIMENTAL

Use of silicone foam dressing and repositioning every 8 hours

Other: Use of silicone foam dressing and repositioning every 8 hours

Group 2

ACTIVE COMPARATOR

Repositioning every 8 hours

Other: Repositioning every 8 hours

Group 3

NO INTERVENTION

Standard care (Control Group)

Interventions

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.

Group 1

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.

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hacettepe University: lead

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Cansu CAMBAZ

CONTACT

+9 0312 305 15 80; cansuyildizoglu65@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 27, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share