## Protocol Section
### Identification Module
**NCT ID:** NCT04761679

**Brief Title:** Nasal Bridge Pressure Injury Prevention

**Official Title:** Nasal Bridge Pressure Injury Prevention Using Protective Dressing and Halyard Fluidshield N95 Mask

#### Organization Study ID Info
**ID:** AAAT2889
#### Organization
**Class:** OTHER
**Full Name:** Columbia University
### Status Module
#### Completion Date
**Date:** 2022-01-04

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-05-19

**Type:** ACTUAL

**Last Update Submit Date:** 2022-05-13

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2022-01-04

**Type:** ACTUAL

#### Start Date
**Date:** 2021-03-23

**Type:** ACTUAL

**Status Verified Date:** 2022-05

#### Study First Post Date
**Date:** 2021-02-21
**Type:** ACTUAL
**Study First Submit Date:** 2021-02-16
**Study First Submit QC Date:** 2021-02-16
**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.
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Columbia University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Pressure Ulcer of Skin

- Pressure Injury

**Keywords:**

- Pressure Injury Prevention

- Personal Protective Equipment

- Nursing

- Nasal Bridge

- N-95 Mask

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Masking Description:** Single-blind design

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 12

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Behavioral: Applying the Mepilex foam

**Label:** Intervention Group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Label:** Control Group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention Group

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

**Name:** Applying the Mepilex foam

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Researchers will count the number of participants with and without injury on the nasal bridge directly between the skin and the N95 mask

**Measure:** Number of Participants with Pressure Injury Prevention

**Time Frame:** 48 hours

#### Secondary Outcomes

**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

**Measure:** Number of Participants that Maintain Mask Seal Integrity

**Time Frame:** 12 hours

### Eligibility Module

**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.

**Maximum Age:** 64 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** New York

**Country:** United States

**Facility:** Columbia University Irving Medical Center/NYP

**State:** New York

**Zip:** 10032

#### Overall Officials

**Official 1:**

**Affiliation:** Columbia University

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

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**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

**IPD Sharing:** YES

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012883

- Term: Skin Ulcer

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC26

- Name: Wounds and Injuries

### Condition Browse Module - Browse Leaves

- ID: M6870

- Name: Pressure Ulcer

- Relevance: HIGH

- As Found: Pressure Injury

- ID: M17206

- Name: Ulcer

- Relevance: LOW

- As Found: Unknown

- ID: M834

- Name: Crush Injuries

- Relevance: HIGH

- As Found: Pressure Injury

- ID: M17685

- Name: Wounds and Injuries

- Relevance: HIGH

- As Found: Injury

- ID: M15686

- Name: Skin Ulcer

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003668

- Term: Pressure Ulcer

- ID: D000014947

- Term: Wounds and Injuries

- ID: D000071576

- Term: Crush Injuries

### Misc Info Module

- Version Holder: 2024-05-24
