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Completed

NCT Number: NCT05299060

Effectiveness of Cyanoacrylate Glue in the Fixation of Midline and Peripherally Inserted Central Catheters in Hospitalized Adult Patients: Randomised Clinical Trial (CIANO-ETI)

Introduction: Venous access is increasingly necessary and essential in healthcare institutions, where more than 75% of hospitalised patients have some type of vascular access device cannulated. Due to their pathophysiological characteristics and pharmacological needs, some patients require special catheters, such as midline or peripherally inserted central catheters. In an attempt to reduce the main complications related to these, the safety of cyanoacrylate tissue adhesive has recently been demonstrated in the post-insertion treatment of vascular access devices.

Objective: To evaluate the efficacy of the use of cyanoacrylate tissue adhesive as fixation in the post-insertion of cannulated middle and central venous catheters with modified micro-Seldinger technique in acute hospitalized patients.

Methods: Randomised clinical trial with two groups(1:1): control and intervention. The control group received a cure with sutureless device plus transparent membrane and the intervention group received the same cure plus the cyanoacrylate glue. The study was approved by the Drug Research Ethics Committee of the Lleida health region. health region.

KEYWORDS: Cyanoacrylates; Vascular Access Device; Catheterization, Peripheral; Nursing Care; Randomized Controlled Trial.

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Key information

Conditions

Vascular Access Device Catheterization, Peripheral Nursing Care Randomized Controlled Trial

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari Arnau de Vilanova

Lleida, Catalonia, 25198, Spain

About this study

A randomized clinical study with two arms (control group and intervention group) was performed.

Patients were selected according to whether they met the inclusion/exclusion criteria and all patients who met the criteria were offered to participate on a voluntary basis. These were collected by the intravenous therapy team (ETI) of the Arnau de Vilanova University Hospital (HUAV) in Lleida, from September 16, 2020 until the completion of the collection of the total number of patients required for the study (n=216).

Patients required insertion of a midline venous catheter (BD-18580 PowerMidline™ 4F) or a peripherally inserted central catheter (BD-20178 PowerPICC™ 4,5 or 6 F), according to the ETI-HUAV algorithm. All insertions were performed with the aid of ultrasound as a guiding technique. In addition, all patients underwent dermatotomy during the technique and the application of a post-insertion hemostasis protocol for at least 2 minutes or until the insertion site stopped bleeding, in order to unify the researchers' criteria.

After insertion of the vascular access device, the control group underwent the standard dressing: transparent polyurethane dressing with reinforced edge (3M®-1655 Tegaderm™ IV) and Sutureless Fixation Device (BD-19940 StatLock™ PICC Plus); and the intervention group, the standard dressing plus application of cyanoacrylate tissue adhesive (SP-015V SecurePortIV™ from Adhezion Biomedical, Llc.).

Afterwards, 3 scheduled cures were performed, at 24 hours, 72 hours and 7 days post-insertion, looking for the main complications: bleeding and/or pericatheter exudate, catheter displacement, signs of phlebitis and catheter-related pain.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • over 18 years of age
  • requiring cannulation of a midline catheter (BD-18580 PowerMidline™ 4F) or a PICC (BD-20178 PowerPICC™ 4.5 or 6 F)
  • who accepted and signed the informed consent voluntarily
  • with an inpatient unit admission of minimum 7 days

Exclusion criteria

  • patients with skin conditions contraindicating the application of a skin glue or known allergy to cyanoacrylate, as recorded in the clinical history

Treatment and study plan

cyanoacrylate adhesive (SecurePortIV®)

Procedure

Application of cyanoacrylate tissue adhesive (SecurePortIV®) to the puncture site plus standard wound care.

standard cure

Procedure

The standard cure 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) and sutureless fixation device (BD-19940 StatLock™ PICC Plus).

Primary outcomes

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

    Time frame: 7 days

    Percentage of participants with adverse events after being treated with cyanoacrylate tissue adhesive at the puncture site after insertion of cannulated middle and central venous catheters with the modified micro-Seldinger technique.

Secondary outcomes

  1. Number of participants with post-treatment hemorrhage assessed by observation (yes/no).

    Time frame: 7 days

    Percentage of participants with pericatheter bleeding 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 for signs of bleeding and it will be noted whether there is bleeding or not.

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

    Time frame: 7 days

    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.

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

    Time frame: 7 days

    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.

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

    Time frame: 7 days

    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.

Sponsors and collaborators

Lead sponsor

Hospital Arnau de Vilanova

Other

Registry information

Acronym: CIANO-ETI

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 28, 2022
Registry last updated
Sep 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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