Clinical trial NCT06770374: Effectiveness of a Zinc Oxide Adhesive Securement Device in the Fixation of Midline and Peripherally Inserted Central Catheters in Hospitalized Adult Patients
Official title: Effectiveness of a Zinc Oxide Adhesive Securement Device in the Fixation of Midline and Peripherally Inserted Central Catheters in Hospitalized Adult Patients: Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vascular Access Complication
Skin and Subcutaneous Tissue Disorders
Phlebitis
Pain
Keywords: Catheters
Vascular Access Devices
Catheter-Related Infections
Nurse Specialists
Nurses
Randomised Controlled Trial
Lead sponsor: Hospital Arnau de Vilanova
Sponsor class: OTHER
Collaborators: name: Official College of Nurses of Lleida
name: Institut Catala de Salut
First posted: 2025-01-13
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Classic parallel model with an intervention group, where the catheters will be fixed with a zinc oxide fixation dressing (Grip-Lok® Ref.2200NUZA), and a control group where the catheters will be fixed with a dressing without zinc oxide (Grip-Lok® Ref.3300MWA).
Primary purpose: PREVENTION

Brief summary: Study in which a zinc oxide fixation device (a product that can help protect the skin) for catheters (polyurethane tubes inserted into a vein) will be tested to reduce catheter-related complications: catheter displacement, skin complications, phlebitis and pain..

Detailed description: Introduction: Midline catheters (MLC) and peripherally inserted central catheters (PICC) are commonly used vascular access devices (VAD) in healthcare institutions where infusion therapies are required, and have been proven to have an optimal level of safety and efficacy for intravenous drug delivery. However, the insertion of these VADs has a number of potential associated complications (immediate, early and/or late), and proper fixation may reduce them.

Hypothesis: Using a universal 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 universal 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 silicone adhesiv(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.

Eligibility criteria: Inclusion Criteria:

* requiring cannulation of a midline catheter or a PICC
* who accepted and signed the informed consent voluntarily
* with an inpatient unit admission of minimum 7 days

Exclusion Criteria:

- patients with a known allergy to zinc oxide

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
timeFrame: 7 days
Secondary outcomes:
measure: Number of participants with altered skin under the sutureless fixation device assessed by observation (yes/no).
timeFrame: 7 days
measure: Number of participants with post-treatment catheter displacement assessed by observation (yes/no).
timeFrame: 7 days
measure: Number of participants with post-treatment phlebitis assessed with the Maddox visual phlebitis rating scale.
timeFrame: 7 days
measure: Number of participants with post-treatment pain in extremity assessed with the EVA scale.
timeFrame: 7 days
Other outcomes:
Locations:
city: Lleida
country: Spain
facility: Arnau de Vilanova Hospital
state: Catalonia
city: Lleida
country: Spain
facility: Hospital Universitari Arnau de Vilanova
state: Cataluña
Study officials:
References:
citation: Huskisson EC, Jones J, Scott PJ. Application of visual-analogue scales to the measurement of functional capacity. Rheumatol Rehabil. 1976 Aug;15(3):185-7. doi: 10.1093/rheumatology/15.3.185.
citation: Babaieasl F, Yarandi HN, Saeidzadeh S, Kheradmand M. Comparison of EMLA and Diclofenac on Reduction of Pain and Phlebitis Caused by Peripheral IV Catheter: A Randomized-Controlled Trial Study. Home Healthc Now. 2019 Jan/Feb;37(1):17-22. doi: 10.1097/NHH.0000000000000704.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Thomsen SL, Boa R, Vinter-Jensen L, Rasmussen BS. Safety and Efficacy of Midline vs Peripherally Inserted Central Catheters Among Adults Receiving IV Therapy: A Randomized Clinical Trial. JAMA Netw Open. 2024 Feb 5;7(2):e2355716. doi: 10.1001/jamanetworkopen.2023.55716.
citation: 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.
citation: Nickel B, Gorski L, Kleidon T, Kyes A, DeVries M, Keogh S, Meyer B, Sarver MJ, Crickman R, Ong J, Clare S, Hagle ME. Infusion Therapy Standards of Practice, 9th Edition. J Infus Nurs. 2024 Jan-Feb 01;47(1S Suppl 1):S1-S285. doi: 10.1097/NAN.0000000000000532. No abstract available.