SecurAstaP trial: securement with SecurAcath versus StatLock for peripherally inserted central catheters, a randomised open trial

Abstract

ObjectivesTo assess the effect on needed nursing time for dressing change.Design, setting, participantsA parallel-group, open-label, randomised controlled trial in patients who are in need for a peripherally inserted central catheter insertion in one teaching hospital in Belgium. The follow-up lasted 180 days or until catheter removal, whatever came first. A computer generated table was used to allocate devices. Randomised patients were 105 adults (StatLock, n=53; SecurAcath, n=52) and primary analysis was based on all patients (n=92) with time measurements (StatLock, n=43; SecurAcath, n=49).InterventionsStatLock which has to be changed weekly versus SecurAcath which could remain in place for the complete catheter dwell time.Main outcome measureNeeded time for the dressing change at each dressing change (SecurAcath) or at each dressing change combined with the change of the securement device (StatLock).ResultsMedian time needed for dressing change was 7.3 min (95% CI 6.4 min to 8.3 min) in the StatLock group and in the SecurAcath group 4.3 min (95% CI 3.8 min to 4.9 min) (P<0.0001). The time in the SecurAcath group was reduced with 41% (95% CI 29% to 51%). Incidence rates of migration, dislodgement and catheter-related bloodstream infection were comparable across groups. Pain scores were higher with SecurAcath than with StatLock at insertion (P=0.02) and at removal (P<0.001) and comparable during dressing change (P=0.38) and during dwell time (P=0.995). User-friendliness was scored at insertion and removal. All statements regarding the user-friendliness were scored significantly higher for StatLock than for SecurAcath (P<0.05). Only for the statement regarding the recommending routine use of the device, which was asked at removal, no difference was found between the two devices (P=0.32).ConclusionUse of SecurAcath saves time during dressing change compared with StatLock. Training on correct placement and removal of SecurAcath is critical to minimise pain.Trial registration numberNCT02311127; Pre-results.

SecurAcath for Securing Peripherally Inserted Central Catheters: A NICE Medical Technology Guidance

“…Only one study directly compared SecurAcath with a competitor product (StatLock); this was a randomised controlled trial (RCT) focusing on the time taken to change a dressing [ 9 ]. Three studies evaluated SecurAcath without a comparator, [ 10 – 12 ] reporting catheter-related adverse events such as migration and dislodgement.…”

“…The EAC critically appraised these studies and presented a narrative review of how they reported the clinical effectiveness of SecurAcath. Eleven studies were deemed to have ‘low’ relevance to the decision problem; six studies were deemed to have ‘medium’ relevance; and one study ‘medium/high’ relevance (the only RCT comparing SecurAcath to a comparator, StatLock) [ 9 ].…”

“…For SecurAcath, six studies included by the manufacturer were used in the meta-analysis [ 10 – 12 , 15 , 16 , 19 ] along with two others identified by the EAC [ 20 , 21 ]. Another eight studies that reported on the comparators (StatLock and suturing) [ 9 , 22 – 28 ] were included by the EAC. Outcome data were extracted and the raw values calculated based on the available evidence.…”

“…Relative risk calculations, based entirely on the single RCT for SecurAcath vs. StatLock, [ 9 ] are presented in Table 1 . The estimates are imprecise owing to the relatively small sample sizes.…”

“…The most relevant study for UK practice that reported pain scores [ 10 ] stated that device removal caused the most dissatisfaction among staff and that patients were complaining of pain or discomfort. Although not included as an outcome in the meta-analysis, the RCT [ 9 ] showed a statistically significant reduction in the time taken to change dressings when SecurAcath was used [4.3 min (95% CI 3.8–4.9) compared with 7.3 min (95% CI 6.4–8.3) for StatLock ( p < 0.0001)]. This had an important bearing on the cost-effectiveness analysis (see below).…”