Nasal Bridge Pressure Injury Prevention

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

Sponsors

Lead Sponsor: Columbia University

Source Columbia University
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.

Overall Status Not yet recruiting
Start Date March 2021
Completion Date April 2021
Primary Completion Date April 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of Participants with Pressure Injury Prevention 48 hours
Secondary Outcome
Measure Time Frame
Number of Participants that Maintain Mask Seal Integrity 12 hours
Enrollment 90
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Applying the Mepilex foam

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

Arm Group Label: Intervention Group

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 64 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Hazel Holder, MSN, RN, ACCNS-AG, CCRN Principal Investigator Columbia University
Overall Contact

Last Name: Hazel Holder, MSN, RN, ACCNS-AG, CCRN

Phone: 914-357-3004

Email: [email protected]

Location
Facility: Contact: Contact Backup: Investigator: Columbia University Irving Medical Center/NYP Hazel Holder, MSN, RN, ACCNS-AG, CCRN 914-357-3004 [email protected] Hazel Holder, MSN, RN, ACCNS-AG, CCRN Principal Investigator
Location Countries

United States

Verification Date

February 2021

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Intervention Group

Type: Experimental

Label: Control Group

Type: No Intervention

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Single (Participant)

Masking Description: Single-blind design

Source: ClinicalTrials.gov