Evaluation of Tissue Glue on PICC and Midline Catheters Insertion Sites

University Hospital Ostrava

Status: Enrolling

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

Treatments: Device: Catheter fixation with glue (cyanoacrylate tissue glue Secure PortIV); Device: Catheter fixation with surgical stitch

Study type: Interventional

Funder types: Other

Identifiers

NCT04900740

FNO-PICC-03

03/RVO-FNOs/2021 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Standard care - catheter fixation with surgical stitch

Active Comparator group

Description:

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.

Treatment:

Device: Catheter fixation with surgical stitch

Experimental - catheter fixation with glue

Experimental group

Description:

In patients indicated for this type of treatment, as per the attending physician, the catheter will be fixed using the glue.

Treatment:

Device: Catheter fixation with glue (cyanoacrylate tissue glue Secure PortIV)