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The feasibility of using hyperoxygenated fatty acids (HOFA) to prevent facial pressure injuries from medical devices. This change occurred before the recruitment of study participants.

A randomised controlled phase II trial to examine the feasibility of using hyperoxygenated fatty acids (HOFA) to prevent facial pressure injuries from medical devices among adults admitted to intensive care – a research protocol.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001072808
Acronym
HOFA
Enrollment
6
Registered
2021-08-13
Start date
2024-08-12
Completion date
2025-08-11
Last updated
2024-10-14

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

Conditions

None listed

Brief summary

Hypothesis: The use of HOFA on patients with facial medical devices will decrease the incidence of facial pressure injuries in the adult ICU population. One in four patients admitted to the ICU will sustain a pressure injury from a medical device (Barakat-Johnson et al., 2017). Pressure injuries (PI) are painful and when sustained to the face can result in permanent disfigurement. Pressure injuries are also very expensive in economic terms representing approximately 1.9% of all public hospital expenditure (Nguyen et al., 2015). This diverts resources from other areas within health care (Slawomirski et al., 2018). Research has established that the cost of prevention for PI in patients at risk is dwarfed by the costs to treat them (Demarré et al., 2015). And, as PI are largely preventable (Slawomirski et al., 2018), medical device-related pressure injuries (MDRPIs) have become a key indicator of patient safety and nursing quality in acute care settings (Jackson et al., 2019). Medical devices pose an increased risk for PI development because the pressure of the device on the skin may cause friction, excessive moisture and increase temperature, which impairs the microclimate. The increased pressure and shearing load are accepted as the causal pathway to the development of pressure injuries (Otero et al., 2017). This project has two primary aims: (1) To assess the effectiveness of HOFAs to prevent facial pressure injuries (FPI) from medical devices in the adult ICU setting; and (2) Assess the implementation and dissemination of the intervention, in particular the acceptability, feasibility, and sustainability among clinical nursing staff.

Interventions

The source population for the feasibility study will be adults admitted to ICU, with facial medical devices (CPAP, BiPAP, ETT, NGT, Nasal prongs, High-flow nasal prongs) as part of their current treatment. The source population for the staff survey and focus groups will be clinical nursing staff from the four ICUs. This study will be undertaken among the Intensive Care population who are expected to be admitted for more than 24 hours. All conscious patients with facial medical devices will be ap

The source population for the feasibility study will be adults admitted to ICU, with facial medical devices (CPAP, BiPAP, ETT, NGT, Nasal prongs, High-flow nasal prongs) as part of their current treatment. The source population for the staff survey and focus groups will be clinical nursing staff from the four ICUs. This study will be undertaken among the Intensive Care population who are expected to be admitted for more than 24 hours. All conscious patients with facial medical devices will be approached to participate in the study. All unconscious patients families with facial medical devices will be approached to participate in the study. The Hyperoxygenated Fatty Acids are wiped onto the participants skin via a swab (similar to an alcohol swab). The HOFA will be applied to areas of the face where medical devices contact the skin. This intervention will be applied once per shift by the individual Registered Nurse (RNs) who is responsible for the patient, the RN will assess at the time of usual care being undertaken every 4 hours. As part of routine nursing care, each study participant will have a skin assessment, that includes the neck, head, and face. This assessment included the classification of the skin as a normal colour, red (blanchable and non-blanchable), and staging of any pressure injuries using NPUAP/EPUAP classification system. This change occurred before the recruitment of study participants.

Sponsors

Leanne Hunt
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Investigator)

Eligibility

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

Inclusion criteria

All adult patients in Intensive Care with facial medical devices (CPAP, BiPAP, ETT, NGT, Nasal prongs, High-flow nasal prongs) as part of their current treatment are eligible to participate in the trial.

Exclusion criteria

Any patient who does not have a medical facial device implemented as part of their current treatment. Patients with significant traumatic facial injuries, burns or facial surgery where Hyperoxygenated Fatty Acids are deemed contraindicated. Patients who at the end-of-life, or are not expected to stay in the ICU for at least 24-hours.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026