Meyer Children's Hospital IRCCS, Firenze
Florence, Italy
Location status: Recruiting
NCT Number: NCT07450729
A venous access device (VADs) is a biocompatible plastic catheter that establishes a connection between the skin surface and a venous system. They can be categorized using various classifications; notably, based on the position of the catheter tip, they are distinguished into central venous catheters (CVCs) and peripheral venous catheters (PVCs). Depending on their length, PVCs can be further divided into long-cannula PVCs and short-cannula PVCs.
Currently, these catheters are stabilized "in situ" using transparent semipermeable dressings with a high moisture vapor transmission rate (MVTR), which keep the insertion site visible. Considering the pediatric patient population, this type of stabilization is currently somewhat archaic, and accidental displacement of PVCs is frequently encountered, along with subsequent complications such as extravasation, occlusion, phlebitis, and local infections.
The addition of skin glue to the transparent semipermeable dressing ensures optimal stabilization of the device, reducing dislodgement, further complications, and consequently the need for multiple punctures for repositioning.
Due to various clinical conditions, some patients presenting to the Emergency Department have a venous network that is difficult to identify by direct visualization or palpation. In these patients, the occurrence of an accidental displacement would significantly compromise the quality of care. Currently, there are no studies in the literature conducted in a pediatric emergency department that demonstrate the superiority of using cyanoacrylate glue for PVC stabilization compared to the semipermeable dressing alone. This study aim to investigate the use of cyanoacrylate glue for stabilizing venous access devices in the emergency setting as well, and to evaluate potential improvements to current daily clinical practice.
The primary objective is to evaluate whether applying cyanoacrylate skin glue at the exit site provides better stabilization of a correctly placed peripheral venous catheter (PVC) compared to PVC stabilization with a transparent semipermeable dressing alone.
Interested in participating?
Request Info0 year–18 year
All sexes
Interventional
Not applicable
Florence, Italy
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Tissue adhesive to properly seal the venipuncture site and fix the catheter optimally to limit the risk of complications.
Time frame: 6 hours post- VADs insertion
Time frame: 12, 24, 36, 48, and 72 hours post- VADs insertion
Time frame: 6, 12, 24, 36, 48, and 72 hours post- VADs insertion
Analysis of the frequency of complications
Time frame: 6, 12, 24, 36, 48, and 72 hours post- VADs insertion
Contact information is provided by the study sponsor or research team.
Meyer Children's Hospital IRCCS
Other
Randomized, Open-label, Parallel-arm, Controlled Study to Evaluate the Stabilization of Peripheral Venous Catheters Through the Application of Cyanoacrylate Skin Adhesive to the Exit Site in Pediatric Patients With Emergency Room Access.
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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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