Innovative dressing and securement of tunneled central venous access devices in pediatrics: a pilot randomized controlled trial

Abstract

BackgroundCentral venous access device (CVAD) associated complications are a preventable source of patient harm, frequently resulting in morbidity and delays to vital treatment. Dressing and securement products are used to prevent infectious and mechanical complications, however current complication rates suggest customary practices are inadequate. The aim of this study was to evaluate the feasibility of launching a full-scale randomized controlled efficacy trial of innovative dressing and securement products for pediatric tunneled CVAD to prevent complication and failure.MethodsAn external, pilot, four-group randomized controlled trial of standard care (bordered polyurethane dressing and suture), in comparison to integrated securement-dressing, suture-less securement device, and tissue adhesive was undertaken across two large, tertiary referral pediatric hospitals in Australia. Forty-eight pediatric participants with newly inserted tunneled CVADs were consecutively recruited. The primary outcome of study feasibility was established by elements of eligibility, recruitment, attrition, protocol adherence, missing data, parent and healthcare staff satisfaction and acceptability, and effect size estimates for CVAD failure (cessation of function prior to completion of treatment) and complication (associated bloodstream infection, thrombosis, breakage, dislodgement or occlusion). Dressing integrity, product costs and site complications were also examined.ResultsProtocol feasibility was established. CVAD failure was: 17% (2/12) integrated securement-dressing; 8% (1/13) suture-less securement device; 0% tissue adhesive (0/12); and, 0% standard care (0/11). CVAD complications were: 15% (2/13) suture-less securement device (CVAD associated bloodstream infection, and occlusion and partial dislodgement); 8% (1/12) integrated securement-dressing (partial dislodgement); 0% tissue adhesive (0/12); and, 0% standard care (0/11). One CVAD-associated bloodstream infection occurred, within the suture-less securement device group. Overall satisfaction was highest in the integrated securement-dressing (mean 8.5/10; standard deviation 1.2). Improved dressing integrity was evident in the intervention arms, with the integrated securement-dressing associated with prolonged time to first dressing change (mean days 3.5).ConclusionsImproving the security and dressing integrity of tunneled CVADs is likely to improve outcomes for pediatric patients. Further research is necessary to identify novel, effective CVAD securement to reduce complications, and provide reliable vascular access for children.Trial registration ACTRN12614000280606; prospectively registered on 17/03/2014.

Flushing of peripheral intravenous catheters: A pilot, factorial, randomised controlled trial of high versus low frequency and volume in paediatrics

“…Based on recruiting of between 5 and 10 patients per month, a factorial RCT that would detect an absolute reduction of 10% in PIVC failure would require approximately 950 participants, which is not feasible in one paediatric hospital. However, a group of paediatric centres could achieve this as a multicentre trial if more extensive ReN hours for recruitment were available (including weekends) so as not to miss PIVCs already in place for >24 h at the time of screening . Once eligible patients were approached for consent, or entered the trial, all feasibility criteria, such as retention and protocol adherence, were satisfactorily met.…”

Skin Complications Associated With Pediatric Central Venous Access Devices: Prevalence, Incidence, and Risk

“…The use of high-quality CVAD dressing products is likely to prevent poor dressing integrity, and potentially CVAD skin complications. However, research in this area is scarce, despite an Australian pilot randomized controlled trial of tunneled CVAD dressing highlighting feasibility and significance (Ullman, Kleidon, Gibson, et al, 2017).…”

“…Over the past 10 years, clinical practice guidelines have been developed to identify and treat specific elements of CVAD-associated skin complications, including skin tears (LeBlanc & Baranoski, 2011), medical adhesive–related skin injury (McNichol et al, 2013), and pressure injuries (National Pressure Ulcer Advisory Panel, 2014). In 2017, Broadhurst et al (2017) published an evidence-based algorithm to assist in the identification, prevention, and treatment of CVAD-associated skin injuries, and they provide a useful summary to inform practice in this area. However, throughout these clinical practice guidelines, the recommendations are frequently based on low-quality evidence, relying on expert opinion and observational studies, especially with regard to dressing selection and skin protective technologies.…”

Innovation in Central Venous Access Device Security: A Pilot Randomized Controlled Trial in Pediatric Critical Care

“…Despite education resources, and one-on-one support from ReNs, CVAD inserting clinicians found TA difficult to apply, especially during the early phases of the trial, and this added complexity to an already difficult CVAD insertion procedure. TA may have a role in the promotion of hemostasis at the CVAD insertion wound, as evident in the prolonged first dressing dwell, reduced need for non-routine dressing changes due to bleeding, and previous studies on other CVAD types (9,10). If some of the practical issues around the application of TA were rectified, the hemostatic properties may be of benefit for some specific patient groups, such as patients recently therapeutically anti-coagulated for cardiac procedures (9).…”

“…Tissue adhesive (TA), or medical grade superglue, provides a physical barrier against microbial entry, promotes hemostasis and offers adhezion between the catheter and insertion site. TA has been successfully trialled with a reduction in failure and complication rates reported in adult intensive care (8), and for other types of CVADs (i.e., tunneled, cuffed CVADs, peripherally inserted central catheters) in pediatric patients (9,10). TA has not been tested in pediatric critical care, where it may be of greatest value.…”