Nasal Bridge Pressure Injury Prevention

NCT ID: NCT04761679

Last Updated: 2022-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-23

Study Completion Date

2022-01-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Pressure Ulcer of Skin Pressure Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
Single-blind design

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention Group

Group Type EXPERIMENTAL

Applying the Mepilex foam

Intervention Type BEHAVIORAL

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

Control Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Applying the Mepilex foam

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Columbia University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

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

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Columbia University Irving Medical Center/NYP

New York, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AAAT2889

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Amnion Wound Covering for Enhanced Wound Healing
NCT03754218 COMPLETED EARLY_PHASE1