None listed
Conditions
Brief summary
Children admitted to an acute care facility frequently require the insertion of a peripherally inserted central catheter (PICC) for the administration of medication and fluids. These PICCs are associated with a high rate of failure, including PICC-related bloodstream infection (BSI). In order to prevent failure, dressings, such as bordered polyurethane (BPU) and sutureless securement devices (SSD), are used to protect the PICC 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 combined securement and dressing products (CSD), are available to clinicians to provide securement and dressings for PICC. It is not known whether these new products are effective at reducing PICC failure and complication, in comparison to standard care (BPU and SSD). 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 PICC failure and complication due to infection, occlusion, dislodgement, thrombosis, or breakage, for children with PICC in acute care.
Interventions
Patients in this study have peripherally inserted central catheters (PICCs) in medical, surgical, anaesthetic and intensive care departments, and only paediatric patients. Consenting parents or legal guardians, and patients (if appropriate) will have their PICCs 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 peripherally inserted central catheters (PICCs) in medical, surgical, anaesthetic and intensive care departments, and only paediatric patients. Consenting parents or legal guardians, and patients (if appropriate) will have their PICCs 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 dressingwill also be applied. Arm 2: Combined securement and dressing product: extra-reinforced borders, with an absorbent layer around the polyurethane claimed to ‘wick’ moisture away from the wound Arm 3 (Control): 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. Bordered polyurethane (BPU) dressings involve a clear polyurethane with an added external adhesive border of foam or cloth fabric. The randomly allocated dressing will be applied until completion of therapy, hospital discharge or at 4 weeks. The dressing will be applied at PICC 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
Inclusion criteria: *Patient requires the insertion of a PICC for >24 hours; *Will remain in admitted to the RCH/LCCH for >24 hours; and *Parent or legal guardian, and child if developmentally appropriate, givesinformed consent.
Exclusion criteria
Exclusion criteria: *Non-tunnelled, tunnelled, dialysis, or implanted CVADs or pulmonary artery catheters; *Current bloodstream infection; *PICC 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