Clinical trial NCT04761679: Nasal Bridge Pressure Injury Prevention
Official title: Nasal Bridge Pressure Injury Prevention Using Protective Dressing and Halyard Fluidshield N95 Mask
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pressure Ulcer of Skin
Pressure Injury
Keywords: Pressure Injury Prevention
Personal Protective Equipment
Nursing
Nasal Bridge
N-95 Mask
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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:

* Exclusion Criteria: A score on \> 5 the COVID Anxiety Scale. The scale has 4 questions with 5 possible options (rated 1 - 5), to evaluate the effect of COVID19 on the individual. The lowest possible score is 0, the highest possible score is 20. A score of 5 states that the individual experiences COVID19 related anxiety for 'Rarely' or 'Not at All". Excluding participants with a score of \> 5 will prevent unnecessary harm to study participants or exacerbate symptoms of anxiety.
* Nurses working in the Emergency Department, Intensive Care Unit or a unit with a focus on the exposed COVID-19 population
* Non-clinical nurses, volunteer or agency registered nurses
* Known history of skin breakdown or damage to the nasal bridge
* History of skin-related conditions including (acne vulgaris, Psoriasis, Herpetic lesions to mouth, nasal areas)
* History of surgery to nasal bridge
* Pregnant nurses in their third trimester
* History of respiratory extended respirator use in addition to the hours collected in this study.

Primary outcomes:
measure: Number of Participants with Pressure Injury Prevention
timeFrame: 48 hours
Secondary outcomes:
measure: Number of Participants that Maintain Mask Seal Integrity
timeFrame: 12 hours
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center/NYP
state: New York
Study officials:
affiliation: Columbia University
name: Hazel Holder, MSN, RN, ACCNS-AG, CCRN
role: PRINCIPAL_INVESTIGATOR
References: