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Nasal Bridge Pressure Injury Prevention

Nasal Bridge Pressure Injury Prevention Using Protective Dressing and Halyard Fluidshield N95 Mask

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04761679
Enrollment
12
Registered
2021-02-21
Start date
2021-03-23
Completion date
2022-01-04
Last updated
2022-05-19

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

Conditions

Pressure Injury, Pressure Ulcer of Skin

Keywords

Pressure Injury Prevention, Personal Protective Equipment, Nursing, Nasal Bridge, N-95 Mask

Brief summary

The primary goal of this study is to explore whether applying the Mepilex foam on the nasal bridge directly between the skin and the N95 mask will prevent nasal bridge pressure injury among nursing staff, secondary to long-term ( \>8+ hours) wear time. The secondary goal is to evaluate if using the Mepilex maintains the seal of the mask.

Detailed description

Nurses use the N95 Mask as part of the personal protective equipment (PPE) when caring for patients with COVID-19. The N95 mask covers their nose and mouth with a tight seal. Nurses wear the mask for more than 8 hours per day, as a result they are at increased risk for skin injury on the nasal bridge. Mepliex is foam dressing which has been used to prevent pressure injuries to the skin. This study will evaluate if using Mepilex or band-aid on the nasal bridge of the nurses who wear the N95 for more than 8 hours decreases the potential for skin injury. In addition, the investigators will test if the Mepilex or band-aid also maintains the seal of the mask. Maintaining the seal is important to ensure that the nurse is not exposed to the virus. The investigators will be working with nurses who do not directly take care of COVID-19 patients to ensure the safety of all participants.

Interventions

BEHAVIORALApplying the Mepilex foam

Mepilex foam will be directly applied on the nasal bridge directly between the skin and the N95 mask.

Sponsors

Columbia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

Single-blind design

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No

Inclusion criteria

* The sample will consist of nursing staff working on non-COVID units, including: Medical Surgical Units, Operating Rooms or Ambulatory Care- Labor and Delivery Unit, Maternity Unit and Medical Oncology Unit, at NewYork-Presbyterian (NYP) Lawrence Hospital.

Exclusion criteria

*

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants with Pressure Injury Prevention48 hoursResearchers will count the number of participants with and without injury on the nasal bridge directly between the skin and the N95 mask

Secondary

MeasureTime frameDescription
Number of Participants that Maintain Mask Seal Integrity12 hoursResearchers will assess the integrity of the N95 mask seal using both interventions - Mepilex and Band-Aid. The number of participants with acceptable seal according to the Fit Test will be counted

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026