Trials / Unknown
UnknownNCT04900740
Evaluation of Tissue Glue on PICC and Midline Catheters Insertion Sites
Evaluation of a Tissue Glue SecurePortIV on Prevention of Phlebitis and Migration of PICC and Midline Catheters in Adult Patients
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- Sponsor
- University Hospital Ostrava · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Catheter fixation with surgical stitch | The catheter will be fixed using the standard procedure - surgical stitch. |
| DEVICE | Catheter fixation with glue (cyanoacrylate tissue glue Secure PortIV) | The catheter will be fixed using the experimental procedure - novel surgical glue. |
Timeline
- Start date
- 2021-05-04
- Primary completion
- 2023-01-31
- Completion
- 2024-12-01
- First posted
- 2021-05-25
- Last updated
- 2023-09-11
Locations
1 site across 1 country: Czechia
Source: ClinicalTrials.gov record NCT04900740. Inclusion in this directory is not an endorsement.