Adult Patients With Mid-term or Long-term Venous AccessNCT04900740
Evaluation of Tissue Glue on PICC and Midline Catheters Insertion Sites
A study testing Catheter fixation with surgical stitch and Catheter fixation with glue (cyanoacrylate tissue glue Secure PortIV) in people with Adult Patients With Mid-term or Long-term Venous Access, run by University Hospital Ostrava at 1 site in Czechia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Patients With Mid-term or Long-term Venous Access
- What is being tested?
- Catheter fixation with surgical stitch and Catheter fixation with glue (cyanoacrylate tissue glue Secure PortIV)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteCzechia
- Study dates
- 4 May 2021to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age
- need of long-term venous access
- consent with participation in the study
Who cannot join
- pediatric population
- not signing the informed consent form
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 708 52
Jiří Hynčica, 0042059737 ext. 2587, jiri.hyncica@fno.cz
Iveta Constantine, Bc., MSc.
About this study
Official title: Evaluation of a Tissue Glue SecurePortIV on Prevention of Phlebitis and Migration of PICC and Midline Catheters in Adult Patients
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.
Read the 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.
- Being tested
- Catheter fixation with surgical stitch, Catheter fixation with glue (cyanoacrylate tissue glue Secure PortIV)
- Keywords
- peripherally inserted central catheter, midline, cyanoacrylate tissue glue, tissue glue, phlebitis, catheter migration
- Medical subject headings
- Phlebitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter fixation with surgical stitchDevice
The catheter will be fixed using the standard procedure - surgical stitch.
Catheter fixation with glue (cyanoacrylate tissue glue Secure PortIV)Device
The catheter will be fixed using the experimental procedure - novel surgical glue.
| Study group | Role | What they receive |
|---|---|---|
| Standard care - catheter fixation with surgical stitch | Active comparator | 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. Receives: Device: Catheter fixation with surgical stitch |
| Experimental - catheter fixation with glue | Experimental | In patients indicated for this type of treatment, as per the attending physician, the catheter will be fixed using the glue. Receives: Device: Catheter fixation with glue (cyanoacrylate tissue glue Secure PortIV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 6 months
Secondary outcomes (1)
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
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start4 May 2021
- Primary completion31 Jan 2023
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Adult Patients With Mid-term or Long-term Venous AccessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Iveta Constantine, Bc., MSc., Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04900740
- Sponsor's protocol ID
- FNO-PICC-03
- Other IDs
- 03/RVO-FNOs/2021
- Status last verified
- Sep 2023
- First submitted
- 13 May 2021
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers.
Publications
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.
PubMed 25959189Di 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.
PubMed 29148010Seckold 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.
PubMed 25634150Gorski 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.
PubMed 33394637Di 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.
PubMed 19127226Igarashi 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.
PubMed 32964580Walshe 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.
PubMed 12149302Pinelli 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.
PubMed 32772785
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Tissue Glue SecurePortIV on Prevention of Phlebitis and Migration of PICC and Midline Catheters in Adult Patients
- ClinicalTrials.gov ID
- NCT04900740
- Acronym / sponsor ID
- FNO-PICC-03
- Keywords
- peripherally inserted central catheter, midline, cyanoacrylate tissue glue, tissue glue, phlebitis, catheter migration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 4 May 2021 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- Dec 2024 (estimated)
- First posted
- 25 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The patients will be enrolled into one of two study groups, depending on the decision of the attending physician.
| Arm | Type | Receives |
|---|---|---|
| Standard care - catheter fixation with surgical stitch | Active comparator | Device: Catheter fixation with surgical stitchIn 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. |
| Experimental - catheter fixation with glue | Experimental | Device: Catheter fixation with glue (cyanoacrylate tissue glue Secure PortIV)In patients indicated for this type of treatment, as per the attending physician, the catheter will be fixed using the glue. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age
- need of long-term venous access
- consent with participation in the study
Key exclusion criteria (2 listed)
- pediatric population
- not signing the informed consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catheter fixation with surgical stitchThe catheter will be fixed using the standard procedure - surgical stitch. | Device | Standard care - catheter fixation with surgical stitch |
| Catheter fixation with glue (cyanoacrylate tissue glue Secure PortIV)The catheter will be fixed using the experimental procedure - novel surgical glue. | Device | Experimental - catheter fixation with glue |
Primary outcome
The incidence of mechanical and infective phlebitis
Time frame: 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
1 secondary outcome
The incidence of external migration of the catheter
Time frame: Up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Background: PubMed 25959189Scoppettuolo 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.
- Background: PubMed 29148010Di 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.
- Background: PubMed 25634150Seckold 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.
- Background: PubMed 33394637Gorski 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.
- Background: PubMed 19127226Di 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.
- Background: PubMed 32964580Igarashi 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.
- Background: PubMed 12149302Walshe 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.
- Background: PubMed 32772785Pinelli 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.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iveta Constantine, Bc., MSc. principal investigator
University Hospital Ostrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter fixation with surgical stitch and Catheter fixation with glue (cyanoacrylate tissue glue Secure PortIV) in people with Adult Patients With Mid-term or Long-term Venous Access, run by University Hospital Ostrava at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiří Hynčica (0042059737 ext. 2587, jiri.hyncica@fno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of mechanical and infective phlebitis (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04900740, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023.