None listed
Conditions
Brief summary
Approximately 240 PICCs are inserted at the Toowoomba Base Hospital (TBH) Medical Imaging department every year, with many of these patients receiving care at TBH but geographically located throughout DDH. Current migration or partial dislodgement rates are recorded locally as being as high as 60%. This is a significant proportion of patients who may be experiencing unnecessary complications requiring additional care and treatment. To our knowledge, there are no RCTs looking at the efficacy of SASS in adult patients requiring a PICC. The aim of our study is to determine if the securement of PICCs with SASS decreases the risk of catheter dislodgement (partial or total) compared to securement with SSD in adult patients. To investigate this at Darling Downs Health, the study team will undertake a randomised controlled trial in adults requiring the insertion of a PICC comparing the use of SASS compared to standard care
Interventions
Patients will be randomised between statlock (Standard of care) or to the SecurAcath (intervention) arm.
The SecurAcath device is a small, subcutaneous anchor securement system that is inserted in the subcutaneous layer, and held in place by small metal feet that act as anchors. The device will be inserted by trained radiology nurse and/or trained medical officer. The device will stay in place for the lifeline of the Peripherally Inserted Central Catheter (PICC) line in the patient - this could
Patients will be randomised between statlock (Standard of care) or to the SecurAcath (intervention) arm. The SecurAcath device is a small, subcutaneous anchor securement system that is inserted in the subcutaneous layer, and held in place by small metal feet that act as anchors. The device will be inserted by trained radiology nurse and/or trained medical officer. The device will stay in place for the lifeline of the Peripherally Inserted Central Catheter (PICC) line in the patient - this could be 1 week or up to 1 year (or more in very rare cases). The SecurAcath device will only be applied the one time. If it is removed or dislodged for any reason, there is no cross-enrolment to the control arm. Strategies used to assess adherence to both arms include monthly follow up with the patient - either in person at appointments or via a phone call.
Sponsors
Darling Downs Health
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
1. 16 years of age or older and requiring PICC insertion in Medical Imaging, Toowoomba Hospital. 2. Informed consent given by patient or substitute decision maker
Exclusion criteria
1. Non-English speakers without an interpreter 2. Unable to consent, or without a legal guardian. 3. Patient receiving end-of-life care 4. Previous enrolment in this study 5. Patients with an indeterminate length of treatment (likely less than 2 weeks) 6. Known allergy to any of the study products (in particular nickel allergy).
Outcome results
None listed