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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Arnau de Vilanova

About this 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..

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Control group: acrylic adhesive sutureless fixation device

    Procedure/Surgery

    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

    Procedure/Surgery

    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

    Device

    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

    Device

    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

    Other intervention

    All punctures will be performed under ultrasound guidance.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: ControlActive comparator 4 interventions
Group B: InterventionExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

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.

Time frame
7 days

Secondary outcomes

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).

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital Arnau de Vilanova

Lead sponsor

Official College of Nurses of Lleida

Collaborator

Department of Health, Generalitat de Catalunya (PERIS)

Collaborator