- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04900740
Evaluation of Tissue Glue on PICC and Midline Catheters Insertion Sites
Evaluation of a Tissue Glue SecurePortIV on Prevention of Phlebitis and Migration of PICC and Midline Catheters in Adult Patients
Study Overview
Status
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jiří Hynčica
- Phone Number: 2587 0042059737
- Email: jiri.hyncica@fno.cz
Study Locations
-
-
Moravian-Silesian Region
-
Ostrava, Moravian-Silesian Region, Czechia, 708 52
- Recruiting
- University Hospital Ostrava
-
Contact:
- Jiří Hynčica
- Phone Number: 2587 0042059737
- Email: jiri.hyncica@fno.cz
-
Principal Investigator:
- Iveta Constantine, Bc., MSc.
-
Sub-Investigator:
- Andrea Polanská, PhDr., MBA
-
Sub-Investigator:
- Magda Michalíková, DiS
-
Sub-Investigator:
- Zuzana Figurová
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
The catheter will be fixed using the experimental procedure - novel surgical glue.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence of external migration of the catheter
Time Frame: 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
|
Up to 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Iveta Constantine, Bc., MSc., University Hospital Ostrava
Publications and helpful links
General Publications
- 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. No abstract available.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FNO-PICC-03
- 03/RVO-FNOs/2021 (Other Grant/Funding Number: University Hospital Ostrava)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Adult Patients With Mid-term or Long-term Venous Access
-
University Hospital OstravaCompleted
-
University of LausanneCentre Hospitalier Universitaire VaudoisCompletedChemotherapy | Long Term Antibiotics | Total Parenteral Nutrition | Central Venous AccessSwitzerland
-
Novartis PharmaceuticalsUniversity of PennsylvaniaRecruitingLong Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access ProgramUnited States, Japan, Australia, Germany, Spain, Belgium, Taiwan, Italy, Canada, Israel, Singapore, United Kingdom, Denmark, Finland, Norway, Austria, Netherlands, France
-
Institut PasteurRecruitingPatients With Uncomplicated Long-term Central Venous Catheter-related Biofilm-related InfectionFrance
-
Federal State Budgetary Institution, V. A. Almazov...Enrolling by invitationAdult Patients of Intensive Care Units on Long-term Lung Mechanical VentilationRussian Federation
-
University Hospital, GasthuisbergCompletedLong-term Oncologic Outcome of MILS in Patients With CRLM and Prognostic IndicatorsBelgium
-
Tel-Aviv Sourasky Medical CenterUnknownPatients Who Are in Need of Short or Long Term Rehabilitation Due to Neurological Event (Mainly Stroke) or Post Orthopedic SurgeryIsrael
-
The First Affiliated Hospital of Anhui Medical...CompletedLong-term Heart-specific Mortality in the Presence of Competing Risks Among Patients With Gastric Adenocarcinoma Undergoing Resection and Chemotherapy
-
HealthPartners InstituteCompletedHemorrhage | Acute Bleeding on Long-Term Anticoagulation Therapy | Significant Bleeding in Patients With a Coagulopathy (Prolonged Thrombin Time) | Urgent Reversal of Vitamin K Antagonist (VKA) AnticoagulationUnited States
-
Sher-E-Bangla Medical CollegeRecruitingTo Assess Long-term Effects of COVID-19 in Patients Who Were Affected With COVID -19Bangladesh
Clinical Trials on Catheter fixation with surgical stitch
-
DuomedCompletedInguinal HerniaBelgium
-
Medical University of ViennaRecruiting
-
Brno University HospitalMasaryk UniversityRecruitingCatheter ComplicationsCzechia
-
University of CalgaryUnity Health Toronto; Queen Elizabeth II Health Sciences Centre; Montreal General... and other collaboratorsRecruiting
-
First Affiliated Hospital Xi'an Jiaotong UniversityNot yet recruiting
-
Sohag UniversityNot yet recruitingMultiple Fractures of Ribs
-
University of Missouri-ColumbiaTerminatedMetacarpal FractureUnited States
-
Sahlgrenska University Hospital, SwedenCompletedRib; Fracture, Multiple, With Flail ChestSweden
-
Cairo UniversityActive, not recruitingVertical Deficeny of Posterior MandibleEgypt
-
Menoufia UniversityCompletedDegenerative Spondylolisthesis G1Egypt