An interventional study of Control group: acrylic adhesive sutureless fixation device and Intervention Group: zinc oxide sutureless fixation device in Vascular Access Complication, Skin and Subcutaneous Tissue Disorders and Phlebitis, sponsored by Hospital Arnau de Vilanova. Completed at 2 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Hospital Arnau de Vilanova · Not applicable, Interventional, and Prevention
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..
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.
496 studies on the registry are indexed under Skin Diseases; 77 are open to participants now.
This study's enrollment of 400 is above the median of 70 across 375 interventional studies indexed under Skin Diseases.
Browse Skin Diseases studies →Hospital Arnau de Vilanova is the lead sponsor of 15 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
- patients with a known allergy to zinc oxide
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
After cannulation of a midline or peripherally inserted central venous catheter with modified micro-Seldinger technique, the control group underwent standard care.
Procedure: Control group: acrylic adhesive sutureless fixation device · Device: PICC · Device: Midline · Other: Ultrasound scanner
After cannulation of a midline or peripherally inserted central venous catheter with modified micro-Seldinger technique, the intervention group underwent the alternative care.
Procedure: Intervention Group: zinc oxide sutureless fixation device · Device: PICC · Device: Midline · Other: Ultrasound scanner
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®).
Also known as: Control
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®).
Also known as: Intervention
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
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
All punctures will be performed under ultrasound guidance.
Also known as: Ultrasound
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.
Time frame: 7 days
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).
Time frame: 7 days
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.
Time frame: 7 days
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.
Time frame: 7 days
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.
Time frame: 7 days
Plan to share: 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.
Supporting information: Study protocol, Informed consent form
Time frame: Open
Access criteria: Will be accessible to everyone through the Mendelay data platform.
Data sharing details ↗ · data.mendeley.com
Ran from Feb 2025 to primary completion in Jul 2026, 17 months.
Of 42 non-industry interventional studies with no phase under Skin Diseases, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 28. This study's 17 months is close to that.
Counting every sponsor, half of 95 studies reached it within 7 months; a quarter within 2 and three quarters within 22.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hospital Arnau de Vilanova