Evaluation of Tissue Glue on PICC and Midline Catheters Insertion Sites

NCT ID: NCT04900740

Last Updated: 2023-09-11

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-04

Study Completion Date

2024-12-31

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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

The patients will be enrolled into one of two study groups, depending on the decision of the attending physician.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

No masking will be used in the study.

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.

Group Type ACTIVE_COMPARATOR

Catheter fixation with surgical stitch

Intervention Type DEVICE

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.

Group Type EXPERIMENTAL

Catheter fixation with glue (cyanoacrylate tissue glue Secure PortIV)

Intervention Type DEVICE

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.

Intervention Type DEVICE

Catheter fixation with glue (cyanoacrylate tissue glue Secure PortIV)

The catheter will be fixed using the experimental procedure - novel surgical glue.

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Ostrava

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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Czechia

Central Contacts

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Jiří Hynčica

Role: CONTACT

0042059737 ext. 2587

Facility Contacts

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Jiří Hynčica

Role: primary

0042059737 ext. 2587

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.

Reference Type BACKGROUND
PMID: 25959189 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29148010 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25634150 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33394637 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19127226 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32964580 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12149302 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32772785 (View on PubMed)

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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