Advice

Clinical and technical evidence

Clinical and technical evidence

A literature search was carried out for this briefing in accordance with the interim process and methods statement for medtech innovation briefings. This briefing includes the most relevant or best available published evidence relating to the clinical effectiveness of the technology. Further information about how the evidence for this briefing was selected is available on request by contacting mibs@nice.org.uk.

Published evidence

Three studies are summarised in this briefing.

One non-randomised comparative study of 62 people (Webber et al. 2020), one observation study of 45 people (Nicholson and Hill, 2019) and one retrospective study of 1,842 newborn babies less than 28 days old (van Rens et al. 2021) are included.

The clinical evidence and its strengths and limitations is summarised in the overall assessment of the evidence.

Overall assessment of the evidence

There are several studies which investigate using cyanoacrylate tissue adhesives for securing different types of catheters in adults, young people and newborn babies less than 28 days old. These studies predominantly include other tissue adhesives which have a similar formulation to SecurePort IV but not identical, because of the type of cyanoacrylate and the additional antimicrobial function of SecurePort IV. The number of studies specifically assessing the use of SecurePort IV is limited and the current literature recognises that larger, randomised trials are needed. One recent study and 1 ongoing study were identified as part of this briefing and are outlined below. Further studies are needed in people with percutaneous catheters to capture the potential benefits of the technology such as reduced rates of infection, reduced bleeding and longer time for dressing change.

The outcomes reported in the literature are relevant to the NHS, but none of the studies outlined have been done in an NHS context.

Webber et al. (2020)

Intervention and comparator(s)

SecurePort IV, compared with chlorhexidine-impregnated disk and engineered stabilisation device.

Key outcomes

There were 31 people in the control group and 31 people in the intervention group, no statistically significant differences were found between the 2 groups for baseline variables. In the control group, 6 observations of catheter migration happened which accounted for 19.35% of the study arm. In the intervention group, no migrations were seen. There was a statistically significant difference (p=0.010) in migration rates between the 2 groups, with the control group having a higher migration rate than the intervention group.

Strengths and limitations

The study time frame was 4 weeks, which is considerably lower than other studies that have assessed the use of tissue adhesives and other catheter securement devices. The study sample size was relatively small and inclusion criteria was limited to inpatients having surgery, which may not be generalisable to the broader population of people who have peripherally inserted central catheters. Also, the antimicrobial effect of SecurePort IV could have been assessed by recording the number of catheter-related infections. A strength of the study was that the technology was compared with the current standard of care for catheter stabilisation and securement, with a clear outcome employed to test efficacy of the intervention.

Nicholson and Hill (2019)

Intervention and comparator(s)

SecurePort IV, no comparator.

Key outcomes

All patients had the insertion site assessed at 3 timepoints: 24 hours, 96 hours and 7 days. The insertion site status was categorised based on the following observations: bleeding, not bleeding, dressing intact and dressing not intact. Of the 45 people included in the study, 42 (93%) had intact dressings and no bleeding observed at all 3 timepoints. Three people did not meet the criteria for tissue adhesive application as they could not achieve haemostasis after 6 minutes of direct manual pressure. They had the following clinical conditions: chronic kidney disease, post-cardiac surgery on high dose anticoagulants and haemophilia dependent on factor product for coagulation. The study authors reported that from using SecurePort IV in this evaluation, they were able to eliminate the standard 24-hour dressing change, experienced savings on supplies and nursing time and increased patient satisfaction.

Strengths and limitations

A strength of the study is that resource use outcomes were observed in addition to clinical outcomes, which allows both cost and time saving benefits to be captured. Although there was no direct comparison of clinical efficacy with standard care or an alternative treatment, efficiency was compared before and after the implementation of SecurePort IV. A limitation of the study is that it was commissioned by the manufacturer. Also, a relatively small study population was included.

Van Rens et al. (2021)

Study size, design and location

A retrospective observational study of 867 neonates with peripherally inserted central catheters who received SecurePort IV compared with 975 neonates who did not receive catheter securement. The study was done in Qatar.

Intervention and comparator(s)

SecurePort IV, compared with no catheter securement.

Key outcomes

The reason for catheter removal was recorded for each case. The most common reason was successful completion of therapy which showed a significant difference between both groups, with 78.0% in the SecurePort IV arm and 65.3% in the comparator arm (p<0.001). Therapy failure because of a complication or death was significantly lower in the tissue adhesive group compared with the no tissue adhesive group, 11.7% versus 27.9% (p<0.001). There was also a statistically significant reduction in the risk of central line-associated bloodstream infection in the SecurePort IV group (65% reduced risk, p<0.001).

Strengths and limitations

A strength of the study is that the patient population included newborn babies under 28 days old, which is one of the patient groups outlined by the company. The broad inclusion criteria allowed for a large sample size which was representative of the neonatal population that are typically treated with peripherally inserted central catheters. A limitation of the study was that it was done at a single centre using a retrospectively collected dataset. In contrast to randomised studies, this methodology can introduce the risk of selection bias.

Sustainability

The company claims the technology will reduce the use of single-use plastics, minimise waste and lower environmental impact through more efficient use of NHS resources. There is no published evidence to support these claims.

Recent and ongoing studies