Advice

Clinical and technical evidence

Clinical and technical evidence

A literature search was carried out for this briefing in accordance with NICE's interim process and methods statement for the production of 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

Six studies are summarised in this briefing. This includes 3 randomised controlled trials, 1 crossover study, 1 prospective audit and 1 prospective comparative study. A total of 1,273 people were included in the studies.

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

Overall assessment of the evidence

The evidence covers different populations, outside adult intensive care, who need securement of a vascular access device. Evidence showed that using Tegaderm CHG IV securement dressing during dialysis and chemotherapy reduced catheter-related infections. However, there was less evidence of a benefit in paediatric intensive care and parenteral nutrition. This could be because the studies were smaller, and because of the low level of bloodstream infections in the control groups. Larger randomised controlled trials are needed in paediatric intensive care and parenteral nutrition. Only 1 study was done in the UK, which may limit generalisability to the NHS.

Biehl et al. (2016)

Intervention and comparator

Intervention: Tegaderm CHG dressing.

Comparator: Standard sterilised dressing.

Key outcomes

Overall incidence of definite and probable catheter-related bloodstream infections (CRBSI) was significantly lower in the Tegaderm CHG group than the control group (10.4% compared with 17.3%; p=0.014). Definite and probable CRBSI infection within 14 days of central venous catheter placement was also significantly lower in the Tegaderm CHG group than the control group (6.5% compared with 11.1%; p=0.047). However, the definite CRBSI rate within 14 days of central venous catheter placement was not significantly different (2.6% for the Tegaderm CHG group and 3.9% for the control group; p=0.375).

Strengths and limitations

This trial has similar demographics, Eastern Cooperative Oncology Group (ECOG) score, duration of neutropenia, and central venous catheter insertion site and type between groups. This study was funded by the company and was not done in the UK.

Apata et al. (2017)

Intervention and comparator

Intervention: Tegaderm CHG dressing.

Comparator: Adhesive dry gauze dressing.

Key outcomes

In phase 1, catheter-related infection rates per 1,000 days at the dialysis centre that switched to using the Tegaderm CHG dressing reduced by 52% (1.69 compared with 0.82 infections per 1,000 days; p<0.05) compared with the pre-intervention period. In phase 2, when the Tegaderm CHG dressings were then introduced at the 2 sites that had been using the comparator, catheter-related infection rates reduced by 86% (1.86 compared with 0.26; p<0.05) and 53% (1.89 compared to 0.88; p<0.05) compared with phase 1.

Strengths and limitations

The demographics of the people in the haemodialysis units were comparable between centres. The catheter-related infection rates were not statistically different during the 12-month pre-intervention period or during the 12-month period when all centres used the Tegaderm CHG dressing. However, this study was not blinded and the change to dressing protocol could have led to improved adherence and so fewer infections. This study was not done in the UK.

Righetti et al. (2016)

Study size, design and location

A randomised crossover study of 59 adults having dialysis with a tunnel central venous catheter in Italy. Patients had treatment for 6 months, then were switched for the next 6 months.

Intervention and comparator

Intervention: Tegaderm CHG dressing.

Comparator: Standard polyurethane dressing.

Key outcomes

The catheter-related infection rate per 1,000 catheter days was reduced from 1.21 with a standard dressing to 0.28 with Tegaderm CHG (p=0.02). The catheter-related bloodstream infection rate per 1,000 catheter days was 0.09 with Tegaderm CHG and 0.65 with a standard dressing (p=0.05).

Strengths and limitations

This study had similar demographics between treatment groups. There was no wash-out period with the intervention switch, which could have affected infection rates in both groups. This study was not done in the UK.

Düzkaya et al. (2016)

Intervention and comparator

Intervention: Tegaderm CHG dressing.

Comparator: Standard sterilised dressing.

Key outcomes

There was no significant difference in local catheter infection, CRBSI, colonisation or contamination rates between the 2 groups.

Strengths and limitations

This was a randomised controlled trial with blinding in the interpretation of microbiological results. The patient demographics between the groups were similar. This study was not done in the UK and the dressings were replaced daily.

Ergul et al. (2018)

Study size, design and location

A prospective, comparative, single-centre study of 131 children in a paediatric intensive care unit in Turkey. The inclusion criterion was jugular vein catheterisation for 48 hours or more.

Intervention and comparator

Intervention: Tegaderm CHG dressing.

Comparator: Transparent polyurethane film dressing.

Key outcomes

There were no statistically significant differences in CRBSI rates between the intervention and control group.

Strengths and limitations

The demographics were similar between the study groups. The Tegaderm CHG dressing was left for 5 to 7 days (or changed as needed) in line with the instructions for use. The standard dressing was changed every 2 days, which may have limited the risk of infection. This study had a small sample size, which may have limited the power to detect significant changes, and it was not randomised.

Madeo and Lowry (2011)

Intervention and comparator

Intervention: Tegaderm CHG dressing.

Comparator: Standard vapour-permeable film dressing.

Key outcomes

The average length of total parenteral nutrition was 10 days. CRBSI reduced from 8 to zero when dressings were switched to Tegaderm CHG, but this was not significant (p=0.057).

Strengths and limitations

This was a small study with limited outcome measures. The study was done in the UK.

Sustainability

The company claims to minimise waste and use renewable resources during product manufacture. It is also improving energy efficiency and increasing its use of renewable sources of energy. There is no published evidence to support these claims.

Recent and ongoing studies

No relevant ongoing or in-development trials were identified.