A comparison of hydrophobic polyurethane and polyurethane peripherally inserted central catheter: results from a feasibility randomized controlled trial.

BACKGROUND: To evaluate the feasibility of an efficacy trial comparing a hydrophobic polyurethane peripherally inserted central catheter (PICC) with a standard polyurethane PICC. METHODS: This pilot randomised controlled trial (RCT) was conducted between May 2017 and February 2018. Adult participants (n = 111) were assigned to hydrophobic polyurethane PICC with proximal valve (intervention) or a polyurethane PICC with external clamp (standard care). Primary outcome was trial feasibility including PICC failure. Secondary outcomes were central line-associated bloodstream infection, local infection, occlusion, thrombosis, fracture and dislodgement, phlebitis, local or systemic allergic reaction, and PICC dwell time. RESULTS: All feasibility outcomes were achieved, apart from eligibility criteria. In total, 338 patients were screened, 138 were eligible (41%), and of these 111 were randomised (80%). Patients received the allocated PICC in 106 (95%) insertions. No patients withdrew from the study and there was no missing data. PICC failure was 24% (13/55) in the intervention group and 22% (12/55) in the standard care group (p = 0.820). PICC failure per 1000 PICC days was 16.3 in the intervention group and 18.4 in the control group (p = 0.755). The average dwell time was 12 days in the intervention and 8 days in the control group. CONCLUSIONS: This study demonstrates the feasibility of an efficacy trial of PICC materials in an adult population, once adjustments were made to include not only in-patients, but also patients being discharged to the Hospital in the Home service. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry ACTRN12616001578493 . Prospectively registered on 16 November 2016. The trial protocol was published a priori (Kleidon et al., Vasc Access 3:15-21, 2017).

Central venous Access device SeCurement And Dressing Effectiveness for peripherally inserted central catheters in adult acute hospital patients (CASCADE): a pilot randomised controlled trial.

BACKGROUND: Peripherally inserted central catheters (PICCs) are commonly used for delivering intravenous therapy. PICC failure is unacceptably high (up to 40%) due to mechanical, infectious and thrombotic complications. Poor securement potentiates all complication types. This randomised controlled trial (RCT) aimed to examine the feasibility of a large RCT of four dressing and securement methods to prevent PICC failure. METHODS: This single-centre pilot RCT included 124 admitted medical/surgical/cancer patients aged ≥ 16 years with a PICC. Interventions were: (i) standard polyurethane dressing and sutureless securement device (SPU + SSD, control); (ii) polyurethane with absorbent lattice pad dressing (PAL + Tape); (iii) combination securement-dressing (CSD); and (iv) tissue adhesive (TA + SPU). All groups except TA + SPU had a chlorhexidine-gluconate (CHG) impregnated disc. Feasibility outcomes were recruitment and safety/acceptability of the interventions. The primary outcome was PICC failure, a composite of PICC removal for local infection, catheter-associated bloodstream infection, dislodgement, occlusion, and/or catheter fracture. Secondary outcomes included individual complications, dressing failure and dwell time, PICC dwell time, skin complications/phlebitis indicators, product costs, and patient and staff satisfaction. Qualitative feedback was also collected. RESULTS: PICC failure incidence was: PAL + CHG + Tape (1/5; 20%; 17.4/1000 days), SPU + SSD + CHG (control) (4/39; 10%; 9.0/1000 days), TA + SPU (3/35; 9%; 9.6/1000 days), and CSD + CHG (3/42; 7%; 9.4/1000 days). Recruitment to PAL + CHG + Tape was ceased after five participants due to concerns of PICC dislodgement when removing the dressing. CSD + CHG, TA + SPU (TA applied only at PICC insertion time), and control treatments were acceptable to patients and health professionals. CONCLUSION: A large RCT of CSD + CHG and TA + SPU (but not PAL + CHG + Tape) versus standard care is feasible. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry, ACTRN12616000027415 . Registered on 15 January 2016.