TumourNCT05776732
Effect of CaviionTM Precaution Medical Adhesive-related Skin Injury in Tumor Patients With PICC Catherizaion
A study testing 3M CaviionTM in people with Tumour, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Malignant tumor patients are at high risk of medical adhesive-related skin injury（MARSI）.MARSI can cause local skin ulceration, increase the difficulty of fixation and maintenance frequency, even cause unplanned extubation, and increase the pain and economic burden of the patient's re-installation.Malignant tumor… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumour
- What is being tested?
- 3M CaviionTM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteChina
- Study dates
- 7 Mar 2022to 30 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For malignant tumor patients newly implanted with PICC,indwelling catheter for more than 1 month，Conduct catheter maintenance in my hospital during observation
Who cannot join
- People with skin disease around PICC tube，Psychopath
Trial locations and contacts
1 site in 1 country.
About this study
Malignant tumor patients are at high risk of medical adhesive-related skin injury（MARSI）.MARSI can cause local skin ulceration, increase the difficulty of fixation and maintenance frequency, even cause unplanned extubation, and increase the pain and economic burden of the patient's re-installation.Malignant tumor patients with long-term PICC are prone to MARSI.CaviionTM can form a protective film on the skin.Applying CaviionTM before using the adhesive can effectively protect the skin and reduce the occurrence of rash.In China, CaviionTM is mostly used in infants and young children, but adults lack corresponding report and application data.Therefore, it is necessary to carry out corresponding randomized controlled study on adult patients, especially malignant tumors
Read the detailed description
The incidence of medical viscose-related skin injury after PICC intubation is as high as 33.15%. The main types of injury are mechanical injury, moisture-related skin injury, contact dermatitis 8.02%, folliculitis.After radiotherapy and chemotherapy, patients with malignant tumors interfere with the formation of new damaged skin cells.Large doses of immunosuppressive agents further weaken the skin barrier and are prone to skin metabolism and immune function disorder.In this study, patients with malignant tumor after PICC intubation were randomly assigned.The experimental group uses CaviionTM, and the control group does not use CaviionTM. Observe the skin condition one month after the tube placement
- Conditions
- Tumour
- Being tested
- 3M CaviionTM
- Keywords
- PICC, medical adhesive-related skin injury
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3M CaviionTMOther
3M CaviionTM is mainly composed of acrylate trimer, non-toxic, alcohol-free, and compatible with chlorhexidine gluconate and povidone iodine.
| Study group | Role | What they receive |
|---|---|---|
| CaviionTM group | Experimental | The first nursing is performed within 48 hours after PICC intubation, and each nursing is not more than 7 days thereafter. The nursing contents include skin disinfection, dressing replacement, flushing and locking venous catheters, needleless connector change. After the disinfectant was dried, the experimental group applied CaviionTM on the skin around the catheter and waited for 30 seconds before sticking the dressing. Receives: Other: 3M CaviionTM |
| Routine care group | No intervention | The first nursing is performed within 48 hours after PICC intubation, and each nursing is not more than 7 days thereafter. The nursing contents include skin disinfection, dressing replacement, flushing and locking venous catheters, needleless connector change. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of medical viscose-related skin injury
Including mechanical injury (exfoliation, skin tear, tension injury), dermatitis (contact dermatitis and allergic dermatitis), others (immersion and folliculitis)
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start7 Mar 2022
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumourStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3M CaviionTM
- Masking
- None (open label)
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776732
- Sponsor's protocol ID
- 研2021-0923
- Status last verified
- Feb 2023
- First submitted
- 15 Feb 2023
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of CaviionTM Precaution Medical Adhesive-related Skin Injury in Tumor Patients With PICC Catherizaion
- ClinicalTrials.gov ID
- NCT05776732
- Acronym / sponsor ID
- 研2021-0923
- Conditions
- Tumour
- Keywords
- PICC, medical adhesive-related skin injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 20 Mar 2023 (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.
Malignant tumor patients are at high risk of medical adhesive-related skin injury（MARSI）.MARSI can cause local skin ulceration, increase the difficulty of fixation and maintenance frequency, even cause unplanned extubation, and increase the pain and economic burden of the patient's re-installation.Malignant tumor patients with long-term PICC are prone to MARSI.CaviionTM can form a protective film on the skin.Applying CaviionTM before using the adhesive can effectively protect the skin and reduce the occurrence of rash.In China, CaviionTM is mostly used in infants and young children, but adults lack corresponding report and application data.Therefore, it is necessary to carry out corresponding randomized controlled study on adult patients, especially malignant tumors
Detailed description
The incidence of medical viscose-related skin injury after PICC intubation is as high as 33.15%. The main types of injury are mechanical injury, moisture-related skin injury, contact dermatitis 8.02%, folliculitis.After radiotherapy and chemotherapy, patients with malignant tumors interfere with the formation of new damaged skin cells.Large doses of immunosuppressive agents further weaken the skin barrier and are prone to skin metabolism and immune function disorder.In this study, patients with malignant tumor after PICC intubation were randomly assigned.The experimental group uses CaviionTM, and the control group does not use CaviionTM. Observe the skin condition one month after the tube placement
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 3M CaviionTM
| Arm | Type | Receives |
|---|---|---|
| CaviionTM group | Experimental | Other: 3M CaviionTMThe first nursing is performed within 48 hours after PICC intubation, and each nursing is not more than 7 days thereafter. The nursing contents include skin disinfection, dressing replacement, flushing and locking venous catheters, needleless connector change. After the disinfectant was dried, the experimental group applied CaviionTM on the skin around the catheter and waited for 30 seconds before sticking the dressing. |
| Routine care group | No intervention | –The first nursing is performed within 48 hours after PICC intubation, and each nursing is not more than 7 days thereafter. The nursing contents include skin disinfection, dressing replacement, flushing and locking venous catheters, needleless connector change. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- For malignant tumor patients newly implanted with PICC,indwelling catheter for more than 1 month，Conduct catheter maintenance in my hospital during observation
Key exclusion criteria (1 listed)
- People with skin disease around PICC tube，Psychopath
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 |
|---|---|---|
| 3M CaviionTM3M CaviionTM is mainly composed of acrylate trimer, non-toxic, alcohol-free, and compatible with chlorhexidine gluconate and povidone iodine. | Other | CaviionTM group |
Primary outcome
Incidence of medical viscose-related skin injury
Time frame: 1year
Including mechanical injury (exfoliation, skin tear, tension injury), dermatitis (contact dermatitis and allergic dermatitis), others (immersion and folliculitis)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3M CaviionTM in people with Tumour, 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 1 inclusion and 1 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 20 Mar 2023. 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 medical viscose-related skin injury (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 20 Mar 2023.