Evaluation of Tissue Glue on PICC and Midline Catheters Insertion Sites

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Device: Catheter fixation with surgical stitch
* Device: Catheter fixation with glue (cyanoacrylate tissue glue Secure PortIV)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The patients will be enrolled into one of two study groups, depending on the decision of the attending physician.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard care - catheter fixation with surgical stitch<br>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<br>* The catheter will be fixed using the standard procedure - surgical stitch.<br>|
| Experimental: Experimental - catheter fixation with glue<br>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)<br>* The catheter will be fixed using the experimental procedure - novel surgical glue.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of mechanical and infective phlebitis | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peripherally inserted central catheter, midline, cyanoacrylate tissue glue, tissue glue, phlebitis, catheter migration