Comparing the Effectiveness of Four Dressing and Securement Methods for Peripherally Inserted Central Catheters: A pilot randomized controlled trial

Abstract

Background: Peripherally inserted central catheters (PICCs) are commonly used for delivering systemic anti-neoplastic therapy. PICC failure is unacceptably high (up to 40%) due to mechanical, infectious and thrombotic complications. Poor securement potentiates all complication types. This randomized 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. 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. PICC failure was approximately 90% less likely in women than in men (HR=0.10, 95%CI=0.01–0.87, p=0.037), but increased fourfold in patients with ≥3 comorbidities, compared to those with one or no comorbidities (HR=4.62, 95%CI=1.04–20.4, p<0.005). Discussion: A large RCT of CSD + CHG and TA + SPU (but not PAL + CHG + Tape) versus standard care is feasible. Male gender may increase the risk of PICC failure due to men being more hirsute, which can disrupt dressing adhesiveness and having more muscle movement. Clinicians should work to ensure best insertion, monitoring and maintenance practice in men, and those with ≥3 comorbidities.