Associated Skin LesionsNCT04913740
Nursing Study of Skin Lesions Related to Health Care Protection in Novel Nursing Study of Skin Lesions Related to Health Care Protection in Novel Coronavirus Epidemic
A study testing Ointment and dressing for external use in people with Associated Skin Lesions, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
In the fight against the epidemic, medical personnel need to wear protective equipment, such as N95 mask, face screen, goggles, latex gloves, waterproof isolation clothing, and have special requirements. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Associated Skin Lesions
- What is being tested?
- Ointment and dressing for external use
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 1 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Job post: fever clinic, COVID-19 throat swab sampling site, isolation ward
- Health care workers who have worked for 30 days or more
- The continuous working time of tertiary protection shall be more than or equal to 4 hours
- Signed the informed consent and volunteered to participate in the study.
Who cannot join
- Existing long-term skin damage
- The skin damage related to protection is too heavy to be studied
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nursing Study of Skin Lesions Related to Health Care Protection COVID-19 Epidemic
In the fight against the epidemic, medical personnel need to wear protective equipment, such as N95 mask, face screen, goggles, latex gloves, waterproof isolation clothing, and have special requirements. Protection-related skin lesions after the use of protective equipment will affect the health and comfort of medical workers. In this study, a retrospective study was conducted on the front-line medical workers in the fight against COVID-19 using questionnaires, so as to understand the incidence, location and clinical manifestations of skin lesions caused by the use of protective equipment by medical workers. And analyze the causes of these skin damage, so as to develop the corresponding prevention and treatment countermeasures, select 170 cases that meet the research conditions, a randomized controlled experiment, divided into control group and experimental group: the control group is on the basis of three-level protection, did not use any preventive measures of health care workers. In the experimental group, skin related prevention was carried out on the basis of three-level protection. The specific interventions are as follows :(1) Focus on protecting exposed skin and making it locally dry. (2) Do a good job of facial moisturizing before work (at least 1 hour before wearing the mask), use moisturizing ointment, longer lasting and non-irritating cream or emulsion, such as vitamin E cream, Vaseline, avoid direct contact with the skin of the mask, choose the appropriate type of protective device; Reduce friction by sticking foam paste, hydrocolloid accessories, ampute and so on on good hair parts. However, it should be noted that it must be confirmed that the airtightness is good, and the primary purpose of the medical staff is to ensure the protective effect. (4) After work, avoid using irritant (such as hot water, exfoliating cream, etc.) to clean the face, and massage local skin with skin moisturizer; (5) In case of severe skin damage, treat as prescribed by the doctor; (6) After finishing the front-line work, "Questionnaire Star" was used to collect data, and all data were input into the statistical software for analysis to compare the index differences between the two groups.
- Conditions
- Associated Skin Lesions
- Being tested
- Ointment and dressing for external use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ointment and dressing for external useOther
- pay attention to the protection of exposed skin, so that it is local dry.
- Do a good job of facial moisturizing work before work use moisturizing ointment, more durable and non-irritating cream or emulsion, such as vitamin E cream, petroleum jelly, to do a good job of moisturizing work.
- Use appropriate dressing to avoid direct contact between the mask and the skin, and select the appropriate type of protective device; Reduce friction by applying foam patches, hydrocolloidal dressings, and empleters to the hair area. However, it should be noted that it must be confirmed that airtightness is good and that the protective effect is still the primary purpose of the medical staff.
- After work, avoid using irritants to clean the face, and massage local skin with skin moisturizer; (5) If severe skin damage occurs, treat it as prescribed by the doctor
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | health care workers who did not use any preventive measures on the basis of tertiary protection |
| Experimental group | Experimental | On the basis of three-level protection, skin correlation prevention is carried out:
1. pay attention to the protection of exposed skin, so that it is local dry.
2. Do a good job of facial moisturizing work before workuse moisturizing ointment, more durable and non-irritating cream or emulsion, such as vitamin E cream, petroleum jelly, to do a good job of moisturizing work.
3. Use appropriate dressing to avoid direct contact between the mask and the skin, and select the appropriate type of protective device; Reduce friction by applying foam patches, hydrocolloidal dressings, and empleters to the hair area. However, it should be noted that it must be confirmed that airtightness is good and that the protective effect is still the primary purpose of the medical staff.
4. After work, avoid using irritantsto clean the face, and massage local skin with skin moisturizer; (5) If severe skin damage occurs, treat it as prescribed by the doctor Receives: Other: Ointment and dressing for external use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of skin damage caused by the use of protective equipment by health care workers
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start1 Jun 2021
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Associated Skin LesionsStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ZeXing Chen, Study chair, supervision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913740
- Sponsor's protocol ID
- 2020-841
- Status last verified
- Jun 2021
- First submitted
- 2 Jun 2021
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nursing Study of Skin Lesions Related to Health Care Protection COVID-19 Epidemic
- ClinicalTrials.gov ID
- NCT04913740
- Acronym / sponsor ID
- 2020-841
- Conditions
- Associated Skin Lesions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 4 Jun 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.
In the fight against the epidemic, medical personnel need to wear protective equipment, such as N95 mask, face screen, goggles, latex gloves, waterproof isolation clothing, and have special requirements. Protection-related skin lesions after the use of protective equipment will affect the health and comfort of medical workers. In this study, a retrospective study was conducted on the front-line medical workers in the fight against COVID-19 using questionnaires, so as to understand the incidence, location and clinical manifestations of skin lesions caused by the use of protective equipment by medical workers. And analyze the causes of these skin damage, so as to develop the corresponding prevention and treatment countermeasures, select 170 cases that meet the research conditions, a randomized controlled experiment, divided into control group and experimental group: the control group is on the basis of three-level protection, did not use any preventive measures of health care workers. In the experimental group, skin related prevention was carried out on the basis of three-level protection. The specific interventions are as follows :(1) Focus on protecting exposed skin and making it locally dry. (2) Do a good job of facial moisturizing before work (at least 1 hour before wearing the mask), use moisturizing ointment, longer lasting and non-irritating cream or emulsion, such as vitamin E cream, Vaseline, avoid direct contact with the skin of the mask, choose the appropriate type of protective device; Reduce friction by sticking foam paste, hydrocolloid accessories, ampute and so on on good hair parts. However, it should be noted that it must be confirmed that the airtightness is good, and the primary purpose of the medical staff is to ensure the protective effect. (4) After work, avoid using irritant (such as hot water, exfoliating cream, etc.) to clean the face, and massage local skin with skin moisturizer; (5) In case of severe skin damage, treat as prescribed by the doctor; (6) After finishing the front-line work, "Questionnaire Star" was used to collect data, and all data were input into the statistical software for analysis to compare the index differences between the two groups.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –health care workers who did not use any preventive measures on the basis of tertiary protection |
| Experimental group | Experimental | Other: Ointment and dressing for external useOn the basis of three-level protection, skin correlation prevention is carried out: 1. pay attention to the protection of exposed skin, so that it is local dry. 2. Do a good job of facial moisturizing work before workuse moisturizing ointment, more durable and non-irritating cream or emulsion, such as vitamin E cream, petroleum jelly, to do a good job of moisturizing work. 3. Use appropriate dressing to avoid direct contact between the mask and the skin, and select the appropriate type of protective device; Reduce friction by applying foam patches, hydrocolloidal dressings, and empleters to the hair area. However, it should be noted that it must be confirmed that airtightness is good and that the protective effect is still the primary purpose of the medical staff. 4. After work, avoid using irritantsto clean the face, and massage local skin with skin moisturizer; (5) If severe skin damage occurs, treat it as prescribed by the doctor |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Job post: fever clinic, COVID-19 throat swab sampling site, isolation ward
- Health care workers who have worked for 30 days or more
- The continuous working time of tertiary protection shall be more than or equal to 4 hours
- Signed the informed consent and volunteered to participate in the study.
Key exclusion criteria (2 listed)
- Existing long-term skin damage
- The skin damage related to protection is too heavy to be studied
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 |
|---|---|---|
| Ointment and dressing for external use1. pay attention to the protection of exposed skin, so that it is local dry. 2. Do a good job of facial moisturizing work before work use moisturizing ointment, more durable and non-irritating cream or emulsion, such as vitamin E cream, petroleum jelly, to do a good job of moisturizing work. 3. Use appropriate dressing to avoid direct contact between the mask and the skin, and select the appropriate type of protective device; Reduce friction by applying foam patches, hydrocolloidal dressings, and empleters to the hair area. However, it should be noted that it must be confirmed that airtightness is good and that the protective effect is still the primary purpose of the medical staff. 4. After work, avoid using irritants to clean the face, and massage local skin with skin moisturizer; (5) If severe skin damage occurs, treat it as prescribed by the doctor | Other | Experimental group |
Primary outcome
Incidence of skin damage caused by the use of protective equipment by health care workers
Time frame: 1year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
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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.
ZeXing Chen study chair
supervision
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ointment and dressing for external use in people with Associated Skin Lesions, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 4 Jun 2021. 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 China. 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?
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?
Incidence of skin damage caused by the use of protective equipment by health care workers (time frame: 1year). 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 4 Jun 2021.