Pressure Ulcer of SkinNCT04761679
Nasal Bridge Pressure Injury Prevention
A study testing Applying the Mepilex foam in people with Pressure Ulcer of Skin and Pressure Injury, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Pressure Ulcer of Skin, Pressure Injury
- What is being tested?
- Applying the Mepilex foam
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2021to 4 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center/NYP
New York, New York, 10032
About this study
Official title: Nasal Bridge Pressure Injury Prevention Using Protective Dressing and Halyard Fluidshield N95 Mask
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.
Read the 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
- Pressure Ulcer of Skin, Pressure Injury
- Being tested
- Applying the Mepilex foam
- Keywords
- Pressure Injury Prevention, Personal Protective Equipment, Nursing, Nasal Bridge, N-95 Mask
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Applying the Mepilex foamBehavioural
Mepilex foam will be directly applied on the nasal bridge directly between the skin and the N95 mask.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Not described Receives: Behavioral: Applying the Mepilex foam |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 hours
Secondary outcomes (1)
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
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start23 Mar 2021
- Primary completion4 Jan 2022
- Study completion4 Jan 2022
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure Ulcer of SkinStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hazel Holder, MSN, RN, ACCNS-AG, CCRN, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761679
- Sponsor's protocol ID
- AAAT2889
- Status last verified
- May 2022
- First submitted
- 16 Feb 2021
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Bridge Pressure Injury Prevention Using Protective Dressing and Halyard Fluidshield N95 Mask
- ClinicalTrials.gov ID
- NCT04761679
- Acronym / sponsor ID
- AAAT2889
- Conditions
- Pressure Ulcer of Skin, Pressure Injury
- Keywords
- Pressure Injury Prevention, Personal Protective Equipment, Nursing, Nasal Bridge, N-95 Mask
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- 4 Jan 2022 (actual)
- Study completion
- 4 Jan 2022 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Applying the Mepilex foam |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Applying the Mepilex foamMepilex foam will be directly applied on the nasal bridge directly between the skin and the N95 mask. | Behavioural | Intervention Group |
Primary outcome
Number of Participants with Pressure Injury Prevention
Time frame: 48 hours
Researchers will count the number of participants with and without injury on the nasal bridge directly between the skin and the N95 mask
1 secondary outcome
Number of Participants that Maintain Mask Seal Integrity
Time frame: 12 hours
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hazel Holder, MSN, RN, ACCNS-AG, CCRN principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Applying the Mepilex foam in people with Pressure Ulcer of Skin and Pressure Injury, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Pressure Injury Prevention (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.