Adult Patients With Mid-term or Long-term Venous Access
Conditions
Keywords
peripherally inserted central catheter, midline, cyanoacrylate tissue glue, tissue glue, phlebitis, catheter migration
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.
Interventions
DEVICECatheter fixation with glue (cyanoacrylate tissue glue Secure PortIV)
The catheter will be fixed using the experimental procedure - novel surgical glue.
DEVICECatheter fixation with surgical stitch
The catheter will be fixed using the standard procedure - surgical stitch.
Sponsors
University Hospital Ostrava
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Masking description
No masking will be used in the study.
Intervention model description
The patients will be enrolled into one of two study groups, depending on the decision of the attending physician.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Czechia
Contacts
Primary ContactJiří Hynčica
Outcome results
None listed