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Evaluation of Tissue Glue on PICC and Midline Catheters Insertion Sites

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Catheter fixation with surgical stitch
Catheter fixation with glue (cyanoacrylate tissue glue Secure PortIV)
Sponsored by
University Hospital Ostrava
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Adult Patients With Mid-term or Long-term Venous Access focused on measuring peripherally inserted central catheter, midline, cyanoacrylate tissue glue, tissue glue, phlebitis, catheter migration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital OstravaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard care - catheter fixation with surgical stitch

Experimental - catheter fixation with glue

Arm Description

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.

In patients indicated for this type of treatment, as per the attending physician, the catheter will be fixed using the glue.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 13, 2021
Last Updated
September 8, 2023
Sponsor
University Hospital Ostrava
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1. Study Identification

Unique Protocol Identification Number
NCT04900740
Brief Title
Evaluation of Tissue Glue on PICC and Midline Catheters Insertion Sites
Official Title
Evaluation of a Tissue Glue SecurePortIV on Prevention of Phlebitis and Migration of PICC and Midline Catheters in Adult Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 4, 2021 (Actual)
Primary Completion Date
January 31, 2023 (Actual)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Ostrava

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Patients With Mid-term or Long-term Venous Access
Keywords
peripherally inserted central catheter, midline, cyanoacrylate tissue glue, tissue glue, phlebitis, catheter migration

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking Description
No masking will be used in the study.
Allocation
Non-Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard care - catheter fixation with surgical stitch
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Experimental - catheter fixation with glue
Arm Type
Experimental
Arm Description
In patients indicated for this type of treatment, as per the attending physician, the catheter will be fixed using the glue.
Intervention Type
Device
Intervention Name(s)
Catheter fixation with surgical stitch
Intervention Description
The catheter will be fixed using the standard procedure - surgical stitch.
Intervention Type
Device
Intervention Name(s)
Catheter fixation with glue (cyanoacrylate tissue glue Secure PortIV)
Intervention Description
The catheter will be fixed using the experimental procedure - novel surgical glue.
Primary Outcome Measure Information:
Title
The incidence of mechanical and infective phlebitis
Description
The incidence of mechanical and infective phlebitis will be measured in the group with the cyanoacrylate tissue glue in comparison with the standard treatment
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
The incidence of external migration of the catheter
Description
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
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiří Hynčica
Phone
0042059737
Ext
2587
Email
jiri.hyncica@fno.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iveta Constantine, Bc., MSc.
Organizational Affiliation
University Hospital Ostrava
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ostrava
City
Ostrava
State/Province
Moravian-Silesian Region
ZIP/Postal Code
708 52
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiří Hynčica
Phone
0042059737
Ext
2587
Email
jiri.hyncica@fno.cz
First Name & Middle Initial & Last Name & Degree
Iveta Constantine, Bc., MSc.
First Name & Middle Initial & Last Name & Degree
Andrea Polanská, PhDr., MBA
First Name & Middle Initial & Last Name & Degree
Magda Michalíková, DiS
First Name & Middle Initial & Last Name & Degree
Zuzana Figurová

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data available to other researchers.
Citations:
PubMed Identifier
25959189
Citation
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.
Results Reference
background
PubMed Identifier
29148010
Citation
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.
Results Reference
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PubMed Identifier
25634150
Citation
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.
Results Reference
background
PubMed Identifier
33394637
Citation
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.
Results Reference
background
PubMed Identifier
19127226
Citation
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.
Results Reference
background
PubMed Identifier
32964580
Citation
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.
Results Reference
background
PubMed Identifier
12149302
Citation
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.
Results Reference
background
PubMed Identifier
32772785
Citation
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.
Results Reference
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Evaluation of Tissue Glue on PICC and Midline Catheters Insertion Sites

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