CompletedPhase 3ACTRN12615000667516

Central venous Access device SeCurement And Dressing Effectiveness in the ICU: the CASCADE ICU Trial

Randomised controlled trial of tissue adhesive, integrated securement products or external stabilisation devices versus standard care (bordered polyurethane) dressings to prevent central venous access device failure in intensive care patients with non-tunnelled, percutaneous central venous access devices: the CASCADE ICU trial


Sponsor

Associate Professor Marion Mitchell

Enrollment

120 participants

Start Date

Nov 30, 2015

Study Type

Interventional

Conditions

Summary

About 500,000 Australians need a Central Venous Access Device (CVAD) each year for intravenous administration of medicines, chemotherapy and fluids. Insertion of these devices poses great procedural risk and complications are common during subsequent use. Between 20 and 50% of CVADs fail prior to treatment being complete. This includes CVADs becoming partially or wholly dislodged, occluded, thrombosis of the vein, fractured catheters, severe pain, or a bloodstream infection. These complications are associated with patient suffering, prolonged hospitalisation, more expensive healthcare costs and increased mortality. Two key factors in preventing complications are (i) securement - that CVADs are adequately secured to the skin, and (ii) dressings - that the incision is covered to prevent infection. CVAD securement has traditionally been via sutures, with a simple polyurethane dressing. This approach (sutures plus simple polyurethane) has been dominant since the 1980s, despite significant evidence of increased bloodstream infections. New alternative securement and dressing options have become available that may be superior to suture and simple polyurethane dressings for preventing complications, but these have not yet been adequately tested for efficacy or cost-effectiveness. CVAD securement and dressings cost the Australian health system millions of dollars each year, yet there is currently no high quality evidence from independent trials to guide decision making and practice on this topic. The proposed study is a high quality, pilot randomised controlled trial, designed to assess the feasibility of undertaking a full-scale efficacy randomised controlled trial, and provide preliminary data for an NHMRC project grant application. The full study would aim identify clinically- and cost-effective securement and dressing approaches that prevent CVAD failure. The 4 group trial will test 3 alternatives to standard care, a novel product – tissue adhesive (medical super-glue), and two commercial alternatives. This design will efficiently and rapidly test numerous treatments. The trial will additionally evaluate the acceptability of products to patients and clinicians, and apply an integrated approach to knowledge translation.


Eligibility

Sex: Both males and femalesMin Age: 16 Yearss

Inclusion Criteria2

  • Informed written consent
  • Non-tunnelled percutaneous CVAD to be inserted in ICU for clinical care for >24 hours

Exclusion Criteria5

  • Peripherally inserted, tunnelled, dialysis, or pulmonary artery catheters;
  • Current bloodstream infection;
  • CVAD to be inserted through diseased, burned, scarred or hirsute skin;
  • Allergy to any study product;
  • Previous study enrolment in this admission

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Interventions

Patients in this study have central venous access devices (CVADs) used in adult intensive care departments. Consenting patients will have their CVADs secured with one of the following randomly assign

Patients in this study have central venous access devices (CVADs) used in adult intensive care departments. Consenting patients will have their 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. Within this study it will be applied to the CVAD insertion site, and used in addition to a chlorhexidine-impregnated bordered polyurethane dressing and sutures. Arm 2: Sutureless Stabilisation Device (SSD) have a large adhesive padded footplate with locking clasp made of hard plastic or self-gripping soft fasteners. SSD are used in addition to bordered polyurethane. Arm 3: Integrated securement and dressing products which combine the durability and visibility of the transparent polyurethane, whilst including an absorbent pad and additional security via bordering. A chlorhexidine-impregnated disc and suture will also be used. Arm 4 (Control): Bordered polyurethane (BPU) dressings involve a clear polyurethane with an added external adhesive border of foam or cloth fabric. They are routinely used in conjunction with suture and are chlorhexidine impregnated. The randomly allocated dressing will be applied until completion of therapy. The dressing will be applied at CVAD insertion and then changed every 7 days, or on disruption of the dressing integrity.


Locations(1)

Princess Alexandra Hospital - Woolloongabba

QLD, Australia

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ACTRN12615000667516