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Vascular Access ComplicationFIX-ETINCT06770374

Effectiveness of a Zinc Oxide Adhesive Securement Device in the Fixation of Midline and Peripherally Inserted Central Catheters in Hospitalized Adult Patients

A study testing Intervention Group: zinc oxide sutureless fixation device, PICC and Midline in people with Vascular Access Complication and Skin and Subcutaneous Tissue Disorders, run by Hospital Arnau de Vilanova at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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.. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Intervention Group: zinc oxide sutureless fixation device, PICC and Midline
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
2 sitesSpain
Study dates
1 Feb 2025to 15 Sep 2026
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

  • 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

Who cannot join

  • patients with a known allergy to zinc oxide

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • Arnau de Vilanova Hospital

    Lleida, Catalonia, 25001

  • Hospital Universitari Arnau de Vilanova

    Lleida, Catalonia, 25198

Other trials in Spain

About this study

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 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..

Read the 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 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.

Being tested
Control group: acrylic adhesive sutureless fixation device, Intervention Group: zinc oxide sutureless fixation device, PICC, Midline, Ultrasound scanner
Keywords
Catheters, Vascular Access Devices, Catheter-Related Infections, Nurse Specialists, Nurses, Randomised Controlled Trial
Medical subject headings
Skin Diseases, Phlebitis, Pain, Catheter-Related Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Control group: acrylic adhesive sutureless fixation deviceProcedure or surgery

    Also called Control

    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 deviceProcedure or surgery

    Also called Intervention

    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®).

  • PICCDevice

    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

  • MidlineDevice

    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 scannerOther

    Also called Ultrasound

    All punctures will be performed under ultrasound guidance.

Study groups in NCT06770374
Study groupRoleWhat they receive
ControlActive comparatorAfter cannulation of a midline or peripherally inserted central venous catheter with modified micro-Seldinger technique, the control group underwent standard care.
Receives: Procedure: Control group: acrylic adhesive sutureless fixation device; Device: PICC; Device: Midline; Other: Ultrasound scanner
InterventionExperimentalAfter cannulation of a midline or peripherally inserted central venous catheter with modified micro-Seldinger technique, the intervention group underwent the alternative care.
Receives: Procedure: Intervention Group: zinc oxide sutureless fixation device; Device: PICC; Device: Midline; Other: Ultrasound scanner

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.

    Percentage of participants with adverse events following cannulation of a midline or peripherally inserted central catheter after fixation with a zinc oxide sutureless fixation device.

    Measured: 7 days

Secondary outcomes (4)

  1. Number of participants with altered skin under the sutureless fixation device assessed by observation (yes/no).

    Percentage of participants with skin alterations under the sutureless fixation device after puncture of a midline or central venous catheter with the modified micro-Seldinger technique. Four examinations will be performed: post puncture, at 24 hours, at 72 hours and at 7 days, in which the puncture site will be visualized for signs of skin alterations and it will be noted whether they exist and what type (Hematoma, Skin Stripping, Tension Injury or Blister, Skin Tear, Irritant Contact Dermatitis, Allergic Contact Dermatitis, Maceration or Folliculitis).

    Measured: 7 days

  2. Number of participants with post-treatment catheter displacement assessed by observation (yes/no).

    Percentage of participants with catheter displacement after puncture of a midline or central venous catheter with the modified micro-Seldinger technique. Four cures will be performed: post puncture, at 24 hours, 72 hours and 7 days, where the puncture site will be visualized to check if the catheter is still in the same point or if it has been displaced.

    Measured: 7 days

  3. Number of participants with post-treatment phlebitis assessed with the Maddox visual phlebitis rating scale.

    Percentage of participants with phlebitis after puncture of a midline or central venous catheter with the modified micro-Seldinger technique. Four cures will be performed: post puncture, at 24 hours, 72 hours and 7 days, where the puncture site will be visualized to check for signs of phlebitis, according to the Maddox scale.

    Measured: 7 days

  4. Number of participants with post-treatment pain in extremity assessed with the EVA scale.

    Percentage of participants with pain in extremity after puncture of a midline or central venous catheter with the modified micro-Seldinger technique. Four cures will be performed: post puncture, at 24 hours, 72 hours and 7 days, where the patient will be asked what pain he/she feels in the extremity related to the catheter.

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2025
  2. Study start1 Feb 2025
  3. Primary completion31 Jul 2026
  4. Study completion15 Sep 2026

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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 (acrylic adhesive) (Grip-Lok® Ref.3300MWA).
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06770374
Sponsor's protocol ID
03/24
Acronym
FIX-ETI
Status last verified
Apr 2026
First submitted
24 Dec 2024
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: The data from the FIX-ETI project were uploaded to Mendelay data, so that the data can be observed and analyzed by the entire scientific community and anyone interested in the subject. The research protocol, the informed consent, the infographic presented to the patients, the data collection notebook and the data collected during all the cures will be uploaded and retrieved from the REDCap database.

Publications

  • 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.

    PubMed 968347

  • 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.

    PubMed 30608463

  • 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.

    PubMed 20334633

  • 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.

    PubMed 17244314

  • 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.

    PubMed 28448263

  • 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.

    PubMed 29602709

  • 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.

    PubMed 37879273

  • 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.

    PubMed 34600737

  • 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.

    PubMed 27126759

  • 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.

    PubMed 26662622

  • 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.

    PubMed 28978332

  • 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.

    PubMed 37725150

  • 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.

    PubMed 34053159

  • 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.

    PubMed 38349655

  • 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.

    PubMed 36751645

Questions about this trial

What is this clinical trial studying?

A study testing Intervention Group: zinc oxide sutureless fixation device, PICC and Midline in people with Vascular Access Complication and Skin and Subcutaneous Tissue Disorders, run by Hospital Arnau de Vilanova at 2 sites in Spain.

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 1 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: finished, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. (time frame: 7 days). 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 NCT06770374, which also lists 17 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 18 Sep 2026.

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