Back to resultsNasal Bridge Pressure Injury Prevention
Primary Purpose
Pressure Ulcer of Skin, Pressure Injury
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Applying the Mepilex foam
Sponsored by
About this trial
This is an interventional prevention trial for Pressure Ulcer of Skin focused on measuring Pressure Injury Prevention, Personal Protective Equipment, Nursing, Nasal Bridge, N-95 Mask
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.
Sites / Locations
- Columbia University Irving Medical Center/NYP
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Group
Control Group
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04761679
Brief Title
Nasal Bridge Pressure Injury Prevention
Official Title
Nasal Bridge Pressure Injury Prevention Using Protective Dressing and Halyard Fluidshield N95 Mask
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
Evolution of the COVID19 pandemic with subsequent spread to all areas of clinical care severely affected the number of potential participants that were able to safely participate in the study.
Study Start Date
March 23, 2021 (Actual)
Primary Completion Date
January 4, 2022 (Actual)
Study Completion Date
January 4, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Columbia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer of Skin, Pressure Injury
Keywords
Pressure Injury Prevention, Personal Protective Equipment, Nursing, Nasal Bridge, N-95 Mask
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Single-blind design
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Applying the Mepilex foam
Intervention Description
Mepilex foam will be directly applied on the nasal bridge directly between the skin and the N95 mask.
Primary Outcome Measure Information:
Title
Number of Participants with Pressure Injury Prevention
Description
Researchers will count the number of participants with and without injury on the nasal bridge directly between the skin and the N95 mask
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Number of Participants that Maintain Mask Seal Integrity
Description
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
Time Frame
12 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hazel Holder, MSN, RN, ACCNS-AG, CCRN
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Irving Medical Center/NYP
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Nasal Bridge Pressure Injury Prevention
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