Evaluation of Tissue Glue on PICC and Midline Catheters Insertion Sites
NCT ID: NCT04900740
Last Updated: 2023-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
250 participants
INTERVENTIONAL
2021-05-04
2024-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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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.
Catheter fixation with surgical stitch
The catheter will be fixed using the standard procedure - surgical stitch.
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.
Catheter fixation with glue (cyanoacrylate tissue glue Secure PortIV)
The catheter will be fixed using the experimental procedure - novel surgical glue.
Interventions
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Catheter fixation with surgical stitch
The catheter will be fixed using the standard procedure - surgical stitch.
Catheter fixation with glue (cyanoacrylate tissue glue Secure PortIV)
The catheter will be fixed using the experimental procedure - novel surgical glue.
Eligibility Criteria
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Inclusion Criteria
* need of long-term venous access
* consent with participation in the study
Exclusion Criteria
* not signing the informed consent form
18 Years
ALL
No
Sponsors
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University Hospital Ostrava
OTHER
Responsible Party
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Principal Investigators
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Iveta Constantine, Bc., MSc.
Role: PRINCIPAL_INVESTIGATOR
University Hospital Ostrava
Locations
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University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia
Countries
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Central Contacts
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Facility Contacts
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References
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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. No abstract available.
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.
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.
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. No abstract available.
Di Giacomo M. Comparison of three peripherally-inserted central catheters: pilot study. Br J Nurs. 2009 Jan 8-21;18(1):8-16. doi: 10.12968/bjon.2009.18.1.32071.
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.
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. doi: 10.1200/JCO.2002.11.135.
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.
Other Identifiers
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03/RVO-FNOs/2021
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
FNO-PICC-03
Identifier Type: -
Identifier Source: org_study_id
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