None listed
Conditions
Brief summary
Hospitals and health systems spend millions of dollars each year on dressings to secure Central Venous Access Devices (CVADs) to patients’ skin. Nurses and doctors spend hours applying and maintaining them; yet 20-40% of CVADs fail prior to treatment being complete, including many that partially or wholly ‘fall out’, become occluded or infect the bloodstream. The proposed study is a randomised control trial, designed to (i) identify clinical, cost-effective methods to prevent CVAD failure due to infection, occlusion, migration and accidental removal; (ii) to compare usual care dressings, with three novel methods; and (iii) to evaluate the acceptability of these devices to patients and health professionals.
Interventions
Patients in this study have central venous access devices (CVADs) used in medical, surgical, anaesthetic and intensive care departments, and include adult and paediatric patients. 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.
Arm 2: Sutureless Stabilisation Dev
Patients in this study have central venous access devices (CVADs) used in medical, surgical, anaesthetic and intensive care departments, and include adult and paediatric patients. 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. 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 standard polyurethane. Arm 3: Absorbent dressings which combine the durability and visibility of the transparent polyurethane, whilst including an absorbent pad. Arm 4 (Control): 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. 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
0 to No maximum
Healthy volunteers
No
Inclusion criteria
1. Informed written consent 2. CVAD to be inserted for clinical care (includes peripherally inserted central catheters, percutaneous central catheters, tunnelled central catheters).
Exclusion criteria
1. Current bloodstream infection 2. Non-English speaking patients without interpreter 3. CVADS inserted through diseased, burned or scarred skin 4. Current skin tear/'paper' skin at high risk of tear 5. Known allergy to any study product 6. Extremely diaphoretic patients
Outcome results
None listed