Effectiveness of a Zinc Oxide Adhesive Securement Device in the Fixation of Midline and Peripherally Inserted Central Catheters in Hospitalized Adult Patients
NCT ID: NCT06770374
Last Updated: 2025-12-23
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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RECRUITING
NA
400 participants
INTERVENTIONAL
2025-02-01
2026-12-31
Brief Summary
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Detailed Description
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Hypothesis: Using a zinc oxide adhesive securement device (ASD) reduces the number of fixation-associated complications in MLC and PICC compared to a universal ASD with silicone adhesive.
Objective: To evaluate the efficacy of using a ASD with zinc oxide for post insertion fixation of MLC and PICC in hospitalised adult patients.
Methodology: Randomised clinical study. Two randomised groups will be created before catheter cannulation. The control group will be cured with an ASD with acrylic adhesive (Grip-Lok® Ref.3300MWA) and the intervention group will be cured with ASD with zinc oxide (Grip-Lok® Ref.2200NUZA).
Expected results: The investigators expect to reduce the number of complications related to the attachment of PICCs and MLCs in adult hospitalised patients following the protocolised placement of a ASD with zinc oxide during the first cure. Specifically, it is expected to reduce the number of catheter dislodgements, the number of medical adhesive-related skin injuries (MARSI) and the amount of phlebitis.
Clinical implication: The study will help to improve decision making related to maintenance and care of VAD in order to reduce the main associated complications.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Control
After cannulation of a midline or peripherally inserted central venous catheter with modified micro-Seldinger technique, the control group underwent standard care.
Control group: acrylic adhesive sutureless fixation device
The standard care consists of:
* Application of hemostasis at the point of insertion for 2 minutes post puncture or until bleeding stops.
* Fix with clear polyurethane dressing (3M®-1655 Tegaderm™ IV), cyanoacrylate glue (SecurePortIV®) and acrylic adhesive sutureless fixation device (3300MWA Grip-Lok®).
PICC
The PICC lines used in the study will all be third-generation polyurethane and of the commercial brands:
* PowerPICC™ 4, 5 and 6 Fr from BD
* Maxflo expert™ 5 and 6 Fr from Vygon
Midline
The midline lines used in the study will be second or third generation polyurethane and of the commercial brands:
* PowerMidline™ 4 Fr from BD
* Arrow® Midline 4Fr from Arrow
Ultrasound scanner
All punctures will be performed under ultrasound guidance.
Intervention
After cannulation of a midline or peripherally inserted central venous catheter with modified micro-Seldinger technique, the intervention group underwent the alternative care.
Intervention Group: zinc oxide sutureless fixation device
Alternative care consisted of:
* Application of haemostasis at the insertion site for 2 minutes post-puncture or until cessation of bleeding.
* Fixation with clear polyurethane dressing (3M®-1655 Tegaderm™ IV), cyanoacrylate glue (SecurePortIV®) and zinc oxide sutureless fixation device (2200NUZA Grip-Lok®).
PICC
The PICC lines used in the study will all be third-generation polyurethane and of the commercial brands:
* PowerPICC™ 4, 5 and 6 Fr from BD
* Maxflo expert™ 5 and 6 Fr from Vygon
Midline
The midline lines used in the study will be second or third generation polyurethane and of the commercial brands:
* PowerMidline™ 4 Fr from BD
* Arrow® Midline 4Fr from Arrow
Ultrasound scanner
All punctures will be performed under ultrasound guidance.
Interventions
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Control group: acrylic adhesive sutureless fixation device
The standard care consists of:
* Application of hemostasis at the point of insertion for 2 minutes post puncture or until bleeding stops.
* Fix with clear polyurethane dressing (3M®-1655 Tegaderm™ IV), cyanoacrylate glue (SecurePortIV®) and acrylic adhesive sutureless fixation device (3300MWA Grip-Lok®).
Intervention Group: zinc oxide sutureless fixation device
Alternative care consisted of:
* Application of haemostasis at the insertion site for 2 minutes post-puncture or until cessation of bleeding.
* Fixation with clear polyurethane dressing (3M®-1655 Tegaderm™ IV), cyanoacrylate glue (SecurePortIV®) and zinc oxide sutureless fixation device (2200NUZA Grip-Lok®).
PICC
The PICC lines used in the study will all be third-generation polyurethane and of the commercial brands:
* PowerPICC™ 4, 5 and 6 Fr from BD
* Maxflo expert™ 5 and 6 Fr from Vygon
Midline
The midline lines used in the study will be second or third generation polyurethane and of the commercial brands:
* PowerMidline™ 4 Fr from BD
* Arrow® Midline 4Fr from Arrow
Ultrasound scanner
All punctures will be performed under ultrasound guidance.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* who accepted and signed the informed consent voluntarily
* with an inpatient unit admission of minimum 7 days
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Official College of Nurses of Lleida
UNKNOWN
Catalan Institute of Health
OTHER_GOV
Hospital Arnau de Vilanova
OTHER
Responsible Party
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Ferran Padilla Nula
Principal Investigator
Locations
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Arnau de Vilanova Hospital
Lleida, Catalonia, Spain
Hospital Universitari Arnau de Vilanova
Lleida, Catalonia, Spain
Countries
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Central Contacts
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Padilla-Nula F Master of Science (MSc), Registred Nurse Certificated
Role: CONTACT
Phone: +34 666115214
Email: [email protected]
Facility Contacts
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Padilla-Nula F, Nursing graduat
Role: primary
References
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Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Med. 2010 Mar 24;8:18. doi: 10.1186/1741-7015-8-18.
Lansdown AB, Mirastschijski U, Stubbs N, Scanlon E, Agren MS. Zinc in wound healing: theoretical, experimental, and clinical aspects. Wound Repair Regen. 2007 Jan-Feb;15(1):2-16. doi: 10.1111/j.1524-475X.2006.00179.x.
Kogan S, Sood A, Garnick MS. Zinc and Wound Healing: A Review of Zinc Physiology and Clinical Applications. Wounds. 2017 Apr;29(4):102-106.
Molina-Mazon CS, Martin-Cerezo X, Domene-Nieves de la Vega G, Asensio-Flores S, Adamuz-Tomas J. Comparative study on fixation of central venous catheter by suture versus adhesive device. Enferm Intensiva (Engl Ed). 2018 Jul-Sep;29(3):103-112. doi: 10.1016/j.enfi.2017.10.004. Epub 2018 Mar 27. English, Spanish.
Xu H, Hyun A, Mihala G, Rickard CM, Cooke ML, Lin F, Mitchell M, Ullman AJ. The effectiveness of dressings and securement devices to prevent central venous catheter-associated complications: A systematic review and meta-analysis. Int J Nurs Stud. 2024 Jan;149:104620. doi: 10.1016/j.ijnurstu.2023.104620. Epub 2023 Oct 9.
Bing S, Smotherman C, Rodriguez RG, Skarupa DJ, Ra JH, Crandall ML. PICC versus midlines: Comparison of peripherally inserted central catheters and midline catheters with respect to incidence of thromboembolic and infectious complications. Am J Surg. 2022 May;223(5):983-987. doi: 10.1016/j.amjsurg.2021.09.029. Epub 2021 Sep 25.
Moureau N, Chopra V. Indications for peripheral, midline and central catheters: summary of the MAGIC recommendations. Br J Nurs. 2016 Apr 28-May 11;25(8):S15-24. doi: 10.12968/bjon.2016.25.8.S15.
Woller SC, Stevens SM, Evans RS. The Michigan Appropriateness Guide for Intravenous Catheters (MAGIC) initiative: A summary and review of peripherally inserted central catheter and venous catheter appropriate use. J Hosp Med. 2016 Apr;11(4):306-10. doi: 10.1002/jhm.2525. Epub 2015 Dec 14.
Chan RJ, Northfield S, Larsen E, Mihala G, Ullman A, Hancock P, Marsh N, Gavin N, Wyld D, Allworth A, Russell E, Choudhury MA, Flynn J, Rickard CM. Central venous Access device SeCurement And Dressing Effectiveness for peripherally inserted central catheters in adult acute hospital patients (CASCADE): a pilot randomised controlled trial. Trials. 2017 Oct 4;18(1):458. doi: 10.1186/s13063-017-2207-x.
Gravdahl E, Steine S, Augestad KM, Fredheim OM. Use and safety of peripherally inserted central catheters and midline catheters in palliative care cancer patients: a retrospective review. Support Care Cancer. 2023 Sep 19;31(10):580. doi: 10.1007/s00520-023-08045-2.
Kleidon TM, Schults JA, Wainwright C, Mihala G, Gibson V, Saiyed M, Byrnes J, Cattanach P, Macfarlane F, Graham N, Shevill E, Ullman AJ. Comparison of midline catheters and peripherally inserted central catheters to reduce the need for general anesthesia in children with respiratory disease: A feasibility randomized controlled trial. Paediatr Anaesth. 2021 Sep;31(9):985-995. doi: 10.1111/pan.14229. Epub 2021 Jun 21.
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Urtecho M, Torres Roldan VD, Nayfeh T, Espinoza Suarez NR, Ranganath N, Sampathkumar P, Chopra V, Safdar N, Prokop LJ, O'Horo JC. Comparing Complication Rates of Midline Catheter vs Peripherally Inserted Central Catheter. A Systematic Review and Meta-analysis. Open Forum Infect Dis. 2023 Jan 18;10(2):ofad024. doi: 10.1093/ofid/ofad024. eCollection 2023 Feb.
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Padilla-Nula F, Bergua-Lorente A, Farrero-Mena J, Escola-Nogues A, Llaurado-Mateu M, Serret-Nuevo C, Bellon F. Effectiveness of cyanoacrylate glue in the fixation of midline catheters and peripherally inserted central catheters in hospitalised adult patients: Randomised clinical trial (CIANO-ETI). SAGE Open Med. 2023 Apr 28;11:20503121231170743. doi: 10.1177/20503121231170743. eCollection 2023.
Other Identifiers
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03/24
Identifier Type: -
Identifier Source: org_study_id