4.1 The company proposed that using the 3M Tegaderm CHG IV securement dressing (Tegaderm CHG) would not result in changes to the current care pathway or need additional resources. The External Assessment Centre agreed with these assumptions.
4.2 Using Tegaderm CHG instead of a standard dressing does not need any special additional training. At the topic selection phase, the Committee received expert advice that confirmed that minimal additional training would be needed.
4.3 The company provided Hospital Episodes Statistics data showing that there were 237,710 adult critical care episodes, 92,710 of which involved stays of over 48 hours, in 2012/13. Based on expert opinion the company estimated that 95% of these patients would need a central venous and/or arterial catheter, providing an estimate of the population for Tegaderm CHG each year of between 88,074 and 225,824. The company estimated that Tegaderm CHG currently accounts for 15% of the dressings used in the population described in the scope. Were the use of Tegaderm CHG to become standard practice, it was assumed that this figure would rise to 80%.
4.4 The company provided supplementary information from 3 randomised controlled trials (Maryniak et al. 2009; Olson et al. 2008; Rupp et al. 2008) on the performance of Tegaderm CHG compared with a standard dressing (either Tegaderm IV or Opsite IV 3000, Smith and Nephew). These studies were not included in the company's main submission because they were not limited to critically ill patients and used non‑validated methods in their nurse‑reported dressing satisfaction and performance outcome measures.
4.5 The External Assessment Centre agreed with the company's decision to exclude these studies form the clinical evidence. The External Assessment Centre collated information on the ease of use and performance of Tegaderm CHG using advice from experts, evidence from the company and from its own searches.
4.6 Maryniak et al. (2009) reported a prospective observational study involving 217 inpatients and outpatients (107 patients had Tegaderm CHG and 110 patients had an unspecified standard dressing). Olson et al. (2008) carried out a randomised controlled trial with 63 hospitalised patients (33 patients had Tegaderm CHG and 30 patients had a standard dressing – Tegaderm IV), some of whom were in intensive care units. Rupp et al. (2008) completed a randomised controlled trial with 60 hospitalised patients (30 patients had Tegaderm CHG and 30 patients had a standard dressing – Opsite IV 3000). All studies were done in the USA, none of them specifically considered critically ill patients and satisfaction with the dressings was judged by the clinical staff. The results showed that the nurses were significantly more satisfied with Tegaderm CHG than with standard dressings in all 3 studies (p<0.05). Tegaderm CHG was reported to provide a more satisfactory dressing securement, was easier to apply and had improved adherence. There were mixed results, and largely insignificant differences, in terms of nurse satisfaction with ease of correct application, transparency (site visibility), ease of dressing removal, and reported patient discomfort levels during dressing wear.
4.7 The External Assessment Centre identified a number of studies comparing the ease of use of Tegaderm CHG against a chlorhexidine gluconate (CHG)‑impregnated sponge. Eyberg et al. (2008) reported a randomised controlled trial comparing Tegaderm CHG against a CHG‑impregnated sponge (Biopatch) in which 12 clinicians were randomly allocated to apply and remove 1 of the dressings on the left or right side of the neck in 12 healthy volunteers. Outcome measures included overall performance, ease of correct application, ease of removal, ability to see the intravenous site, ease of training and intuitive application. Clinicians found that Tegaderm CHG was significantly better than the CHG‑impregnated sponge across all outcome measures (p<0.05). There were 2 poster presentations (Zehrer et al. 2009; Deschneau et al. 2008) that reported on questionnaires completed by nurses after using the dressings. In both studies Tegaderm CHG performed significantly better overall than the CHG‑impregnated sponge.
4.8 Advice provided during evaluation from 3 experts with experience of using both Tegaderm CHG and standard dressings was that, in general, clinician experience of applying and removing Tegaderm CHG was similar to standard dressings. There was 1 expert who stated that it takes longer to remove Tegaderm CHG and that there may be a few incorrect applications at first. The remaining 2 experts stated that the time taken to apply or remove the dressing is the same or similar for both Tegaderm CHG and standard dressings.
4.9 There were 2 experts who had experience of using both Tegaderm CHG and CHG‑impregnated sponge dressings. They reported minimal differences between the ease of use of the 2 types of dressings. One expert suggested that applying and removing Tegaderm CHG is quicker than for the CHG‑impregnated sponge. The other reported that some nurses had placed the CHG‑impregnated sponge upside down and therefore had to use a replacement.
4.10 Based on evidence from the company, the External Assessment Centre and expert advice, the Committee was satisfied that Tegaderm CHG would not involve significant changes to current care pathways and the use of existing care bundles.
4.11 The Committee was advised by clinical experts that care bundles are of great importance in minimising infection rates. It was advised that care bundles include many components and that it is difficult to identify any specific components that are driving the improvement in infection rates. The Committee concluded that Tegaderm CHG could contribute to preventing catheter-related bloodstream infections (CRBSI) but it would not replace the need for existing infection control practices.
4.12 The Committee was advised by specialists that being able to see the catheter insertion site is useful, allowing early recognition of any dermatitis or infection. Redness at the catheter insertion site can be an early sign of infection, which may be considered with other clinical signs to raise suspicion of CRBSI. The Committee noted that not all CRBSI is associated with visible changes at the insertion site.
4.13 The Committee noted that the cost savings associated with adopting Tegaderm CHG instead of a standard dressing depend on baseline CRBSI rates (see section 5.24). The Committee considered that it was important for intensive care and high dependency units to review their local CRBSI rates when considering whether to adopt Tegaderm CHG.