None listed
Conditions
Brief summary
Adults 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), absorbent dressings, 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. 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 adults with PICC in acute care.
Interventions
Patients in this study have peripherally inserted central catheters (PICCs) in medical, surgical, anaesthetic and intensive care departments.. Patients or substitute decision makers (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 dressing will
Patients in this study have peripherally inserted central catheters (PICCs) in medical, surgical, anaesthetic and intensive care departments.. Patients or substitute decision makers (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 dressing will 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. A chlorhexidine-impregnated disc will also be used. Arm 3: An absorbent polyurethane dressing: a tri-layer dressing made up of a low adherent wound contact layer, a lattice shaped absorbent pad and a top film that is waterproof and is coated with a water-based adhesive. A chlorhexidine-impregnated disc is also to be used. Arm 4 (Control): Sutureless Stabilisation Device (SSD) have a large adhesive padded footplate with locking clasp made of hard plastic. SSD are used in addition to polyurethane dressing and a chlorhexidine-impregnated disc. The randomly allocated dressing will be applied until completion of therapy, hospital discharge or at four dressing changes. The dressing will be applied at PICC insertion and then changed every 7 days, or on disruption of the dressing integrity.
Sponsors
Royal Brisbane and Women's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
*Patients 16 years of age or above *PICCs to be inserted for clinical care *Informed consent to participate
Exclusion criteria
*Current bloodstream infection *Non-English speakers without interpreter *PICCs inserted through diseased, burned or scarred skin *Other types of central venous access devices other than PICCs *Current skin tear/‘papery’ skin at high risk of tear *Known allergy to any study product *Previous enrolment in the current study
Outcome results
None listed