Nasal Bridge Pressure Injury Prevention | NCT04761679

Studies
Nasal Bridge Pressure Injury Prevention

NCT04761679

Sponsor

Columbia University

Status

Terminated

Last Update Posted

May 19, 2022Actual

Enrollment

12Actual

Phase

Not Applicable

Conditions

Pressure Ulcer of Skin
Pressure Injury

Interventions

Applying the Mepilex foam

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

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.

Expanded Access Info

Start Date

Mar 23, 2021Actual

Primary Completion Date

Jan 4, 2022Actual

Completion Date

Jan 4, 2022Actual

First Submitted Date

Feb 16, 2021

First Submission Date that Met QC Criteria

Feb 16, 2021

First Posted Date

Feb 21, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 13, 2022

Last Update Posted Date

May 19, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention Group	Experimental		Behavioral: Applying the Mepilex foam
Control Group	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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	12 hours

Other Outcomes

Not provided

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

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

Facility	Status	City	State	ZIP	Country	Contacts
Columbia University Irving Medical Center/NYP		New York	New York	10032	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D012883	Skin Ulcer
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases