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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Tumour
• Intervention / Treatment: Other: 3M CaviionTM

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 Type: Interventional
• Enrollment (Anticipated): 165
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • ZhwJiang
    • Hangzhou, ZhwJiang, China, 310009
      • 石芸

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• People with skin disease around PICC tube，Psychopath

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CaviionTM group; 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; 3M CaviionTM is mainly composed of acrylate trimer, non-toxic, alcohol-free, and compatible with chlorhexidine gluconate and povidone iodine.
No Intervention: Routine care group; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2022
• Primary Completion (Anticipated): October 30, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: February 15, 2023
• First Submitted That Met QC Criteria: March 8, 2023
• First Posted (Actual): March 20, 2023

Study Record Updates

• Last Update Posted (Actual): March 20, 2023
• Last Update Submitted That Met QC Criteria: March 8, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: PICC; medical adhesive-related skin injury
• Other Study ID Numbers: 研2021-0923

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No