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

ConditionPressure Injury Prevention

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorHacettepe University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Use of silicone foam dressing and repositioning every 8 hours
Other intervention
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 intervention
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.

Treatment groups

75 Participants

are divided into 3 treatment groups

Group A: Group 1Experimental treatment 1 intervention

Group B: Group 2Active comparator 1 intervention

Group C: Group 3No intervention 0 interventions

Trial outcomes

Primary outcomes

Assessment of whether a ETT related oral mucosa pressure injury develop

Endotracheal Tube-Related Pressure Injury Assessment Form

Time frame

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hacettepe University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: