Specialist commentator comments

Comments on this technology were invited from clinical experts working in the field and relevant patient organisations. The comments received are individual opinions and do not represent NICE's view.

Two of the 3 specialist commentators were familiar with this technology. None of the commentators had used EpiFix in people. One commentator stated that they had not had the opportunity to do research involving the device and another stated that the cost of EpiFix had prevented them from using it.

Level of innovation

Two specialist commentators stated that EpiFix was a minor variation on current technologies. One commentator noted that these types of dressings were usually used in ophthalmology. The third specialist commentator stated that EpiFix appeared to be novel.

Potential patient impact

Two specialist commentators agreed that EpiFix might lead to improved outcomes for people with chronic and difficult-to-heal wounds. One noted that it may be of particular benefit in reducing the risk of deep infection. Improved healing would lead to fewer hospital visits for people with chronic wounds and reduced risk of infection and limb amputation leading to significant quality-of-life improvements. Both commentators stated that there was currently not enough evidence to support these claims. One commentator noted that there was a high level of overlap and potential for reporting bias in the current studies and that more, independent studies would be needed to confirm these benefits. The third specialist commentator stated that there was not enough evidence to show any potential patient benefit and that the technology needs to be formally evaluated in a well-designed, powered, blinded randomised controlled trial.

Potential system impact

Two specialist commentators stated that users of EpiFix would need a short training session with a product specialist. No change to the way services are delivered would be needed. Two specialist commentators noted that using EpiFix could lead to a decreased burden and cost on wound-care services but that more evidence is needed to confirm this. One commentator noted that if the initial study results were replicated in a well-powered, randomised controlled trial and compared with standard NHS treatments, EpiFix could have the potential to significantly change wound care. The third specialist commentator stated that there was not enough evidence to imply any potential system benefit.

General comments

One specialist commentator pointed out limitations in the evidence presented. They stated that most of studies were done by the same investigators and were sponsored by the manufacturer. They state that these trials took place in the US and are not representative of practice in the UK. The commentator also stated that the inclusion and exclusion criteria used in the studies were narrow and did not adequately reflect the population with diabetic foot ulcer. They pointed out that, in the 1 study where the criteria were widened (Kirsner et al. 2015), similar healing rates were not seen.