Evaluation of Tissue Glue on PICC and Midline Catheters Insertion Sites

September 8, 2023 updated by: University Hospital Ostrava

Evaluation of a Tissue Glue SecurePortIV on Prevention of Phlebitis and Migration of PICC and Midline Catheters in Adult Patients

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Czechia
    • Moravian-Silesian Region
      • Ostrava, Moravian-Silesian Region, Czechia, 708 52
        • Recruiting
        • University Hospital Ostrava
        • Contact:
        • Principal Investigator:
          • Iveta Constantine, Bc., MSc.
        • Sub-Investigator:
          • Andrea Polanská, PhDr., MBA
        • Sub-Investigator:
          • Magda Michalíková, DiS
        • Sub-Investigator:
          • Zuzana Figurová

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard care - catheter fixation with surgical stitch
In patients indicated for this type of treatment, as per the attending physician, the catheter will be fixed in the standard way, using a surgical stitch.
Device: Catheter fixation with surgical stitch
The catheter will be fixed using the standard procedure - surgical stitch.
Experimental: Experimental - catheter fixation with glue
In patients indicated for this type of treatment, as per the attending physician, the catheter will be fixed using the glue.
Device: Catheter fixation with glue (cyanoacrylate tissue glue Secure PortIV)
The catheter will be fixed using the experimental procedure - novel surgical glue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of mechanical and infective phlebitis
Time Frame: 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
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of external migration of the catheter
Time Frame: 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
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Ostrava

Investigators

  • Principal Investigator: Iveta Constantine, Bc., MSc., University Hospital Ostrava

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2021

Primary Completion (Actual)

January 31, 2023

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

May 13, 2021

First Submitted That Met QC Criteria

May 24, 2021

First Posted (Actual)

May 25, 2021

Study Record Updates

Last Update Posted (Actual)

September 11, 2023

Last Update Submitted That Met QC Criteria

September 8, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FNO-PICC-03
  • 03/RVO-FNOs/2021 (Other Grant/Funding Number: University Hospital Ostrava)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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