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

NCT05299060 | Completed

• 1 other identifier: 01-20
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vascular Access Device; Catheterization, Peripheral; Nursing Care; Randomized Controlled Trial

Keywords

Cyanoacrylates; Cyanoacrylate; Tissue adhesive

Outcome Measures

Primary Outcomes (1)

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

  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.

  7 days

Secondary Outcomes (4)

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

  7 days

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

  7 days

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

  7 days

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

  7 days

Study Arms (2)

Control

ACTIVE COMPARATOR

After cannulation of a midline catheter or peripherally inserted central venous catheter with modified micro-Seldinger technique, the control group underwent standard care.

Procedure: standard cure

Intervention

EXPERIMENTAL

After cannulation of a midline catheter or peripherally inserted central venous catheter with a modified micro-Seldinger technique, the intervention group underwent the standard treatment plus application of cyanoacrylate tissue adhesive (SecurePortIV®) at the puncture site.

Procedure: cyanoacrylate adhesive (SecurePortIV®)

Interventions

cyanoacrylate adhesive (SecurePortIV®) PROCEDURE

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

Intervention

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).

Control

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Arnau de Vilanova: lead

Study Sites (1)

Hospital Universitari Arnau de Vilanova

Lleida, Catalonia, 25198, Spain

Location

Related Publications (28)

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Study Officials

• Ferran Padilla-Nula

  Arnau de Vilanova hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The investigators are the ones who performed the insertion of the catheters and the subsequent data collection, but neither the patients nor the healthcare staff knew which patient was wearing tissue adhesive.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Classical parallel model with an intervention group, to which cyanoacrylate tissue adhesive was applied, and a control group.

Study Record Dates

• First Submitted: February 26, 2022
• First Posted: March 28, 2022
• Study Start: September 16, 2020
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: September 8, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data is already available, there is no time limit.
• Access Criteria: Be a researcher or group of researchers.

Locations

ES (1)