With new technologies the question is often asked, where does it fit in? With the case of Amniotic Tissue and EpiFix® and to ensure the NHS gets best value for money this needs to be carefully considered.
Whilst the evidence is very strong for EpiFix it clearly has to be used at the right time and once the correct pathways have been followed. A clear and simple way to maximise the use of Amniotic Tissue is the ‘Step Down, Step Up’ model recently seen in the JWC International Consensus – Implementing TIMERS: the race against hard-to-heal wounds.
The question is what happens when you have implemented a thorough pathway and you haven’t achieved 50% closure at 4-6 weeks? This is where the paper suggests it is time for a new strategy. Whilst this post isn’t focused on the pathway and SOC treatments, the most important components of effective SOC are*:
- Early intervention
- Accurate assessment and diagnosis of the patient and wound
- Optimal patient and wound management strategy
- Appropriately-skilled health professionals
- Early referral to specialists
You can see that within the TIME, updated to the TIMER, model below EpiFix should be considered within the realm of a slow or stalled healing wound where conservative therapy is failing or failed*
*JWC International Consensus - Implementing TIMERS: the race against hard-to-heal wounds.
*Image taken from the JWC International Consensus - Implementing TIMERS: the race against hard-to-heal wounds.
It is fundamentally important when selecting an advanced therapy such as EpiFix that an holistic approach is considered. There are numerous factors for consideration in this instance:
- Size and area of the wound
- Patient adherence and understanding of the treatment; careful consideration of the social situation and personal goals are key
- Funding pathways and relevant business cases
- Length of time any wound has remained unhealed
- Has the patient received the relevant standard of care and the wound closure rate is suitable to trigger such therapies?
Step Down, Step Up: How to position EpiFix in the treatment plan where a stalled or failure to close has occurred
When you have addressed the fundamentals of treating the patient, have moved away from management of the wound to healing and you are in a situation where the healing rate has slowed down or you simply haven’t achieved 40/50% closure rates, then with the correct assessment of the patient and their needs, advanced therapies can play a very successful role in healing.
Consider the proposed Step-Down and then Step-Up biofilm pathway. Adapted from Schultz et al, this offers a clear pathway to select an advanced therapy and when. You will have:
- Suitably debrided and managed all the associated risk factors
- Assessed the needs for bacteria and antimicrobials
- Continued to assess healing, carried out maintenance debridement and managed associated risk factors with standard of care treatments
- STEP UP – Consider advanced therapies when standard of care hasn’t achieved 40/50% closure
*Step-up biofilm pathway Adpated from Schultz et al
Debridement and EpiFix
To support healing and ensure that the use of an advanced therapy such as EpiFix is maximised, debridement is key; focusing on devitalised or non-viable tissue that does not contribute to healing and infact may well play a role in delaying healing or indeed facilitating infection.
There are numerous types of debridement (please refer to JWC International Consensus – Implementing TIMERS: the race against hard-to-heal wounds for a comprehensive review of the process, considerations, when not to and the various methods). The latest two RCTs looking at Epifix in hard to heal DFUs demonstrated that good debridement had a huge impact on the rate of healing in these wound types and is a safe and effective way of stimulating the wound (please click on the link to review one of these RCTs).
A well debrided wound gives the patient, you and EpiFix the best chance of success and is fundamental to successful healing, the video below looks at this process in detail:
Finding a place for EpiFix from a financial perspective
Ensuring there is a clear pathway is the first step in providing a solid model for introducing an advanced therapy and building a business case. Demonstrating appropriate use supports the financial elements of treating patients with advanced therapies such as EpiFix.
Building a case? The continued rise in cost of not doing anything far outweighs the initial up-front cost of the therapy. EpiFix clearly shows that in these circumstances the economics are strong and ensures it is a viable option. There are a number of studies demonstrating the burden to the UK healthcare system in regards to woundcare.
Evidence based practice: With numerous level 1 studies (you can find these on the website) demonstrating significant healing rates in DFU and VLU, EpiFix is a proven technology for hard to heal and non-healing wounds.
It is true that these type of technologies are not for every patient and need to be selected carefully, with a robust criteria. In this well selected sub set of patients therapies like EpiFix can make a significant impact on patient care, healing wounds and improving the social and economic burden of non-healing wounds.
How to apply
Finally we take a look at application of EpiFix, this post isn’t focussed on this aspect of the process but we wanted to show you the simplicity of applying Amniotic Tissue with a Chorion layer. Please take a look at how Leanne Atkin is applying EpiFix to help her patients. Behind the scenes there are some specific protocols to follow with regard to human tissue but these are simple and easy to manage making the whole process relatively easy.