Evaluation of Tissue Glue on PICC and Midline Catheters Insertion Sites
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital Ostrava | Ostrava | Moravian-Silesian Region | Czechia | 708 52 |
Sponsors and Collaborators
- University Hospital Ostrava
Investigators
- Principal Investigator: Iveta Constantine, Bc., MSc., University Hospital Ostrava
Study Documents (Full-Text)
None provided.More Information
Publications
- Di Giacomo M. Comparison of three peripherally-inserted central catheters: pilot study. Br J Nurs. 2009 Jan 8-21;18(1):8-16. Retraction in: Br J Nurs. 2014 May 8-21;23(9):S25.
- Di Puccio F, Giacomarro D, Mattei L, Pittiruti M, Scoppettuolo G. Experimental study on the chemico-physical interaction between a two-component cyanoacrylate glue and the material of PICCs. J Vasc Access. 2018 Jan;19(1):58-62. doi: 10.5301/jva.5000816.
- Gorski LA, Hadaway L, Hagle ME, Broadhurst D, Clare S, Kleidon T, Meyer BM, Nickel B, Rowley S, Sharpe E, Alexander M. Infusion Therapy Standards of Practice, 8th Edition. J Infus Nurs. 2021 Jan-Feb 01;44(1S Suppl 1):S1-S224. doi: 10.1097/NAN.0000000000000396.
- Igarashi A, Okuno T, Shimizu T, Ohta G, Ohshima Y. Mechanical stimulation is a risk factor for phlebitis associated with peripherally inserted central venous catheter in neonates. Pediatr Int. 2021 May;63(5):561-564. doi: 10.1111/ped.14476. Epub 2021 May 7.
- Pinelli F, Balsorano P, Mura B, Pittiruti M. Reconsidering the GAVeCeLT Consensus on catheter-related thrombosis, 13 years later. J Vasc Access. 2021 Jul;22(4):501-508. doi: 10.1177/1129729820947594. Epub 2020 Aug 8.
- Scoppettuolo G, Dolcetti L, Emoli A, La Greca A, Biasucci DG, Pittiruti M. Further benefits of cyanoacrylate glue for central venous catheterisation. Anaesthesia. 2015 Jun;70(6):758. doi: 10.1111/anae.13105.
- Seckold T, Walker S, Dwyer T. A comparison of silicone and polyurethane PICC lines and postinsertion complication rates: a systematic review. J Vasc Access. 2015 May-Jun;16(3):167-77. doi: 10.5301/jva.5000330. Epub 2015 Jan 23. Review.
- Walshe LJ, Malak SF, Eagan J, Sepkowitz KA. Complication rates among cancer patients with peripherally inserted central catheters. J Clin Oncol. 2002 Aug 1;20(15):3276-81.
- FNO-PICC-03
- 03/RVO-FNOs/2021