Effect of CaviionTM Precaution Medical Adhesive-related Skin Injury in Tumor Patients With PICC Catherizaion

NCT05776732 | Unknown

• 1 other identifier: 研2021-0923
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief 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 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

Conditions

Tumour

Keywords

PICC; medical adhesive-related skin injury

Outcome Measures

Primary Outcomes (1)

• 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)

  1year

Study Arms (2)

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.

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.

Interventions

3M CaviionTM OTHER

3M CaviionTM is mainly composed of acrylate trimer, non-toxic, alcohol-free, and compatible with chlorhexidine gluconate and povidone iodine.

CaviionTM group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For malignant tumor patients newly implanted with PICC,indwelling catheter for more than 1 month，Conduct catheter maintenance in my hospital during observation

You may not qualify if:

• People with skin disease around PICC tube，Psychopath

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

石芸

Hangzhou, ZhwJiang, 310009, China

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3M CaviionTM

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: March 20, 2023
• Study Start: March 7, 2022
• Primary Completion: October 30, 2023
• Study Completion: December 30, 2023
• Last Updated: March 20, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)