None listed
Conditions
Brief summary
Children admitted to a paediatric intensive care unit (PICU) frequently require the insertion of a CVAD for the administration of medication and fluids. These CVADs are associated with a high rate of failure, including CVAD-related bloodstream infection (BSI). In order to prevent failure, dressings, such as bordered polyurethane (BPU), are used to protect the CVAD insertion site from contamination. Additional securement devices, such as sutures, are used to reduce movement of the catheter. New products, including tissue adhesive (TA), sutureless securement devices (SSD), and combined securement and dressing products (CSD), are available to clinicians to provide securement and dressings for CVAD. It is not known whether these new products are effective at reducing CVAD failure, in comparison to standard care (BPU and suture). The primary aim of this research is to evaluate the feasibility of launching a full-scale efficacy trial, using pre-defined feasibility criteria for recruitment, retention and protocol fidelity. The secondary aim is to compare the effectiveness of dressings and securement products on CVAD failure due to infection, occlusion, dislodgement, thrombosis, or breakage, for children with percuteanous CVAD in the PICU.
Interventions
Patients in this study have central venous access devices (CVADs) used in paediatric intensive care departments. Consenting parents or legal guardians, and patients (if appropriate) will have their percutanaeous CVADs secured
with one of the following randomly assigned dressings and securements:
Arm 1: Tissue Adhesive (TA) is a medical grade 'superglue'
(cyanoacrylate) used mainly to close skin lacerations/wounds as an alternative to sutures and staples. A bordered polyurethane dressing will als
Patients in this study have central venous access devices (CVADs) used in paediatric intensive care departments. Consenting parents or legal guardians, and patients (if appropriate) will have their percutanaeous CVADs secured with one of the following randomly assigned dressings and securements: Arm 1: Tissue Adhesive (TA) is a medical grade 'superglue' (cyanoacrylate) used mainly to close skin lacerations/wounds as an alternative to sutures and staples. A bordered polyurethane dressing will also be applied. Arm 2: Sutureless Stabilisation Device (SSD) have a large adhesive padded footplate with locking clasp made of hard plastic. SSD are used in addition to bordered polyurethane. Arm 3: Combined securement and dressing product: extra-reinforced borders, with an absorbent layer around the polyurethane claimed to ‘wick’ moisture away from the wound Arm 4 (Control): Bordered polyurethane (BPU) dressings involve a clear polyurethane with an added external adhesive border of foam or cloth fabric. They will also have their CVAD secured with prolene sutures. The randomly allocated dressing will be applied until completion of therapy, hospital discharge or at 4 weeks. The dressing will be applied at CVAD insertion and then changed every 7 days, or on disruption of the dressing integrity.
Sponsors
Griffith University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
No minimum to 16 Years
Healthy volunteers
No
Inclusion criteria
Inclusion criteria: *Patient requires the insertion of a percutaneous CVAD for >24 hours; *Will remain in admitted to the RCH/LCCH for >24 hours; * Less than 16 years of age; and *Parent or legal guardian, and child if developmentally appropriate, gives informed consent.
Exclusion criteria
Exclusion criteria: *Tunnelled, peripherally inserted, dialysis, or implanted CVADs or pulmonary artery catheters; *Current bloodstream infection; *CVAD to be inserted through diseased, burned or scarred skin; *Allergy to study product; and *Previous study enrolment in this admission to hospital
Outcome results
None listed