Evaluation of Tissue Glue on PICC and Midline Catheters Insertion Sites

Not Applicable

Recruiting

• Conditions: Adult Patients With Mid-term or Long-term Venous Access

• Registration Number: NCT04900740
• Lead Sponsor: University Hospital Ostrava

Brief Summary

The study will evaluate a new type of cyanoacrylate tissue glue Secure PortIV on the insertion site of the PICC (Peripherally inserted central catheter) or Midline catheters. Fixation of the catheter with the tissue glue should prevent incidents of mechanical and infective phlebitis as well as external migrations of the catheters.

Detailed Description

In the study, 125 subjects will receive the new tissue glue Secure PortIV and 125 subjects will be provided standard care. The tissue glue will be applied immediately after insertion. Evaluation and re-evaluation of the site will be done on the first and seventh day after insertion using VIP and CLISA (Central-Line Insertion Site Assessment) scale and on the seventh day with taking a swab from the insertion site; the external length will be measured on the first and the seventh day, in order to observe the migration or not.

The goal of the study is to evaluate the benefits of the cyanoacrylate tissue glue Secure PortIV in the prevention of mechanical and infective phlebitis and external migration of the catheter.

Study Timeline

• Study Start: 2021-05-04
• Study First Submitted: 2021-05-13
• Study First Submitted QC: 2021-05-24
• Study First Posted: 2021-05-25
• Primary Completion: 2023-01-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-08
• Last Update Posted: 2023-09-11
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• 18 years of age
• need of long-term venous access
• consent with participation in the study

Exclusion Criteria

• pediatric population
• not signing the informed consent form

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The incidence of mechanical and infective phlebitis	Up to 6 months	The incidence of mechanical and infective phlebitis will be measured in the group with the cyanoacrylate tissue glue in comparison with the standard treatment

Secondary Outcome Measures

Name	Time	Method
The incidence of external migration of the catheter	Up to 6 months	The incidence of external migration of the catheter will be measured in the group with the cyanoacrylate tissue glue in comparison with the standard treatment

Trial Locations

Locations (1)

University Hospital Ostrava; 🇨🇿 Ostrava, Moravian-Silesian Region, Czechia