Nasal Bridge Pressure Injury Prevention

NCT04761679 | Terminated

• 1 other identifier: AAAT2889
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Pressure Ulcer of Skin; Pressure Injury

Keywords

Pressure Injury Prevention; Personal Protective Equipment; Nursing; Nasal Bridge; N-95 Mask

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Participants that Maintain Mask Seal Integrity

  12 hours

Study Arms (2)

Intervention Group

EXPERIMENTAL

Behavioral: Applying the Mepilex foam

Control Group

NO INTERVENTION

Interventions

Applying the Mepilex foam BEHAVIORAL

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

Intervention Group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center/NYP

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Hazel Holder, MSN, RN, ACCNS-AG, CCRN

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single-blind design
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 21, 2021
• Study Start: March 23, 2021
• Primary Completion: January 4, 2022
• Study Completion: January 4, 2022
• Last Updated: May 19, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)