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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.

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 18
Healthy Volunteers: f
View:

• Age 0-18 years old

• Venous access device for at least 24 hours.

• Informed consent form signed

Locations
Other Locations
Italy
Meyer Children's Hospital IRCCS, Firenze
RECRUITING
Florence
Contact Information
Primary
Giulia Caccia, Principal Investigator
giulia.caccia@meyer.it
0555662629
Time Frame
Start Date: 2025-01-14
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 300
Treatments
Experimental: Experimental group
No_intervention: Standard of care
Related Therapeutic Areas
Sponsors
Leads: Meyer Children's Hospital IRCCS

This content was sourced from clinicaltrials.gov