None listed
Conditions
Brief summary
Children admitted to the paediatric intensive care unit 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) and chlorhexidine-impregnated discs, 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), and integrated securement and dressing products (ISD), 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 and complication due to infection, occlusion, dislodgement, thrombosis, or breakage, for children with non-tunnelled CVAD in the paediatric intensive care.
Interventions
Patients in this study have central venous access devices (CVADs) used in to assist treatment while they are admitted to the paediatric intensive care unit. Consenting parents or legal guardians, andpatients (if appropriate) will have their non- tunnelled 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 stap
Patients in this study have central venous access devices (CVADs) used in to assist treatment while they are admitted to the paediatric intensive care unit. Consenting parents or legal guardians, andpatients (if appropriate) will have their non- tunnelled 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, prolene suture and a chlorhexidine-impregnated disc will also be applied. Arm 2: Integrated dressing - securement product: extra-reinforced borders, with an absorbent layer around the polyurethane claimedto ‘wick’ moisture away from the wound. This will be used in addition to prolene suture and a chlorhexidine-impregnated disc. Arm 3 (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 and a chlorhexidine-impregnated disc. 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 18 Years
Healthy volunteers
No
Inclusion criteria
*Patients < 18 years of age *Will remain admitted to the Lady Cilento Children’s Hospital for >24 hours *Informed consent to participate *Non-tunnelled CVAD to be inserted and will remain insitu for >24 hours
Exclusion criteria
*All other intravascular device types (e.g. peripherally inserted central catheters, totally implanted CVADs, peripheral intravascular devices) *Current bloodstream infection *Non-English speakers without an interpreter *CVADs inserted through diseased burned or scarred skin *Known allergy to any study product *Current skin tear / ‘papery’ skin at high risk of tear *Previous enrolment in the study within this hospital admission
Outcome results
None listed