Nasal Bridge Pressure Injury Prevention

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

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.

Study Overview

• Status: Terminated
• Conditions: Pressure Ulcer of Skin; Pressure Injury
• Intervention / Treatment: Behavioral: Applying the Mepilex foam

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center/NYP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group	Behavioral: Applying the Mepilex foam; Mepilex foam will be directly applied on the nasal bridge directly between the skin and the N95 mask.
No Intervention: Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Pressure Injury Prevention	Researchers will count the number of participants with and without injury on the nasal bridge directly between the skin and the N95 mask	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants that Maintain Mask Seal Integrity	Researchers 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	12 hours

Collaborators and Investigators

• Sponsor: Columbia University
• Investigators: Principal Investigator: Hazel Holder, MSN, RN, ACCNS-AG, CCRN, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2021
• Primary Completion (Actual): January 4, 2022
• Study Completion (Actual): January 4, 2022

Study Registration Dates

• First Submitted: February 16, 2021
• First Submitted That Met QC Criteria: February 16, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): May 19, 2022
• Last Update Submitted That Met QC Criteria: May 13, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Nursing; Pressure Injury Prevention; Personal Protective Equipment; Nasal Bridge; N-95 Mask
• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Wounds and Injuries; Crush Injuries; Pressure Ulcer
• Other Study ID Numbers: AAAT2889

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Coded participant data will be made available to future researchers with a goal to replicate this study and add to the body of nursing knowledge

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No