Effectiveness of Cyanoacrylate Glue in the Fixation of Midline and Peripherally Inserted Central Catheters in Hospitalized Adult Patients: Randomised Clinical Trial (CIANO-ETI)
Condition: Vascular Access Device; Catheterization, Peripheral; Nursing Care; Randomized Controlled Trial
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): cyanoacrylate adhesive (SecurePortIV®); standard cure
Intervention type(s): Procedure; Procedure
Intervention description(s): Application of cyanoacrylate tissue adhesive (SecurePortIV®) to the puncture site plus standard wound care.; 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).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Classical parallel model with an intervention group, to which cyanoacrylate tissue adhesive was applied, and a control group.
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Cyanoacrylates; Cyanoacrylate; Tissue adhesive