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Dressings used over the nasal bridge for patients undergoing Acute Non-Invasive Ventilation therapy: A randomised, controlled non-inferiority trial of two dressings for pressure injury prevention and patient and nurse satisfaction.

Dressings used over the nasal bridge for patients undergoing Acute Non-Invasive Ventilation therapy: A randomised, controlled non-inferiority trial of two dressings for pressure injury prevention and patient and nurse satisfaction.

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000211167
Enrollment
118
Registered
2019-02-13
Start date
2022-02-28
Completion date
2023-01-27
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Pressure injuries, also known as pressure ulcers, pressure sores or bedsores, are a usually preventable adverse outcome of hospitalisation. Pressure injuries may cause a patient pain or increase their hospital length of stay, and in severe cases may lead to death. Some pressure injuries are related to the use of medical devices, such as the nasal bridge when a non-invasive ventilation (NIV) mask is in place. These pressure injury may be prevented by a protective dressing applied over the nasal bridge. The aim of this study is to compare two dressings used over the nasal bridge for patients undergoing NIV therapy for pressure injury prevention. Patients initiated on NIV therapy within an Australian tertiary hospital who are recruited will be randomly allocated to have one of the dressings applied to their nasal bridge under the NIV mask. Until NIV therapy is ceased, or for up to 7 days, research and ward nurses will monitor the patient for pressure injury and collect information (e.g. information about pressure injury risk and prevention, NIV usage, nurse and patient satisfaction with the dressing). There is currently minimal research and no guidelines on which to base the decision of which dressing to use to prevent pressure injury when a patient is receiving acute NIV. The results of this study will provide information to assist in evaluating these dressings for future use in pressure injury prevention in NIV intervention. The results may present a way of selecting the most appropriate dressing for standard use or for meeting certain patient criteria.

Interventions

Intervention: Use of the Mepilex Border Lite™ 4x5cm (Molnlycke) all-in-one thin foam dressing on the nasal bridge of patients undergoing acute non-invasive ventilation therapy in the study setting. Data will be collected for all patients assigned to the study for the duration of their acute non-invasive ventilation treatment, up to a maximum of 7 days, or until a pressure injury develops. Dressings will only be changed as required as according to usual practice (Hospital Wound Management Policy

Intervention: Use of the Mepilex Border Lite™ 4x5cm (Molnlycke) all-in-one thin foam dressing on the nasal bridge of patients undergoing acute non-invasive ventilation therapy in the study setting. Data will be collected for all patients assigned to the study for the duration of their acute non-invasive ventilation treatment, up to a maximum of 7 days, or until a pressure injury develops. Dressings will only be changed as required as according to usual practice (Hospital Wound Management Policy); frequency of such changes form part of the data to be collected. A standardised data collection form will be used to record all data with fidelity, adherence and accuracy of recording checked by a research nurse assistant. All other standard pressure injury strategies as specified in the International Prevention and Treatment of Pressure Ulcers - Clinical Practice Guidelines (National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel and Pan Pacific Pressure Injury Alliance, 2014) will be used as usual by the registered nurse caring for the patient, including the lifting of the dressing to check for pressure injuries.

Sponsors

The Prince Charles Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Inclusion criteria • Adults over 18 years • Fitted with a vented NIV mask for the purpose of non-invasive ventilation.

Exclusion criteria

Exclusion criteria • Pre-existing nasal bridge pressure injury. • Documented allergy to adhesives used in the two dressings. • Patients who refuse to change NIV mask when clinically indicated • Patients who refuse to wear a nasal bridge dressing under the NIV mask.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026