Effectiveness of Cyanoacrylate Glue in the Fixation of Midline and Peripherally Inserted Central Catheters in Hospitalized Adult Patients: Randomised Clinical Trial (CIANO-ETI)
NCT ID: NCT05299060
Last Updated: 2022-09-08
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
216 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-09-16
Study Completion Date
2021-09-30
Brief Summary
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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.
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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Detailed Description
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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.
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.
Conditions
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Vascular Access Device
Catheterization, Peripheral
Nursing Care
Randomized Controlled Trial
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Classical parallel model with an intervention group, to which cyanoacrylate tissue adhesive was applied, and a control group.
Primary Study Purpose
PREVENTION
Blinding Strategy
DOUBLE
Participants
Caregivers
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.
Study Groups
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Control
After cannulation of a midline catheter or peripherally inserted central venous catheter with modified micro-Seldinger technique, the control group underwent standard care.
Group Type
ACTIVE_COMPARATOR
standard cure
Intervention Type
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).
Intervention
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.
Group Type
EXPERIMENTAL
cyanoacrylate adhesive (SecurePortIV®)
Intervention Type
PROCEDURE
Application of cyanoacrylate tissue adhesive (SecurePortIV®) to the puncture site plus standard wound care.
Interventions
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cyanoacrylate adhesive (SecurePortIV®)
Application of cyanoacrylate tissue adhesive (SecurePortIV®) to the puncture site plus standard wound care.
Intervention Type
PROCEDURE
standard cure
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).
Intervention Type
PROCEDURE
Eligibility Criteria
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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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
99 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Hospital Arnau de Vilanova
OTHER
Sponsor Role
lead
Responsible Party
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Ferran Padilla Nula
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Ferran Padilla-Nula
Role: PRINCIPAL_INVESTIGATOR
Arnau de Vilanova hospital
Locations
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Hospital Universitari Arnau de Vilanova
Lleida, Catalonia, Spain
Site Status
Countries
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Spain
References
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Other Identifiers
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01-20
Identifier Type: -
Identifier Source: org_study_id
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