Advice
The technology
The technology
EpiFix (MiMedx) amniotic membrane allograft is made of dehydrated human amnion/chorion membrane tissue (dHACM). The tissue is derived from amniotic membranes donated with informed consent in the US. EpiFix is terminally sterilised to reduce virus transmission. It is promoted to enhance wound healing, reduce scar tissue formation and modulate inflammation.
EpiFix is indicated for a wide range of wounds; the scope of this briefing is chronic difficult-to-heal wounds including diabetic foot ulcers, venous leg ulcers, arterial ulcers and pressure ulcers.
The company's instructions for use recommend weekly administration. After wound cleaning and debridement in a non-infected wound, EpiFix is removed from the packaging and cut to fit the size of the wound. After EpiFix is applied, a non-adherent contact layer should be placed on top and the wound dressed as usual. EpiFix can be used alongside compression, offloading, negative pressure and hyperbaric oxygen therapy.
Innovations
The innovative aspect of EpiFix is that it is an allograft of human amniotic membrane that has been processed and purified for use (using the MiMedx proprietary PURION process). This is designed to preserve bioactive components and deliver non-viable cells, multiple extracellular matrix (ECM) proteins, active growth factors, cytokines, chemokines and other specialty proteins present in amniotic tissue with the aim of helping to regenerate soft tissue.
Current NHS pathway or current care pathway
Chronic difficult-to-heal wounds such as diabetic foot ulcers, venous leg ulcers, arterial ulcers and pressure ulcers, are typically assessed by a health professional and categorised. Information from this is then used to guide treatment options. Different treatments are offered depending on the type of wound, and its assessment and categorisation. Wound dressings are used as the basis for treating most wounds, and will be used alongside other options such as compression bandaging, offloading, wound debridement, and control of any underlying problems such as wound ischaemia, and nutritional support. For chronic non-healing wounds, most simple conventional dressings (such as basic wound contact or gauze dressings) are not useful. The wound may progress onto needing more advanced dressings (such as hydrocolloids, alginates and hydrofibre dressings) and other treatment, such as negative pressure wound therapy, dermal or skin substitutes.
The following guidelines and advice have been identified as being relevant to this care pathway.
NICE advice
NICE advice also states that the least costly dressings that meet the required clinical performance characteristics should be used, because there is not enough evidence to determine whether advanced dressings (such as hydrocolloids, alginates and hydrofibre dressings) are more clinically effective than conventional dressings.
Population, setting and intended user
EpiFix would most likely be used in place of other advanced wound dressings including dermal substitutes in people with chronic wounds that are not healing at the expected rate, alongside standard interventions such as compression bandaging.
EpiFix is intended for use by a health professional, and may be used in a community or hospital setting. EpiFix is applied by the same clinical staff that would usually choose, apply and change the person's dressings. This would typically be a nurse, but may also include other staff such as GPs and podiatrists.
Costs
Technology costs
EpiFix is available in a number of different sizes; costs range from £348.50 for a 16 mm diameter disc to £1,018.39 for a 2 cm × 3 cm sheet.
The company estimates that 5 weekly treatments (2 cm × 3 cm) will heal a wound leading to a total cost of £5,091.95 for EpiFix. Smaller sheets of EpiFix may be used if the wound heals or gets smaller, reducing costs as treatment progresses.
EpiFix is used as an adjunct to standard care. Total care costs would also include debridement, cleaning, dressing and compression. The total treatment cost will be governed by the frequency of dressing changes, total treatment length and any additional treatment needs.
Costs of standard care
There is no standard agreed list of dressings used in chronic wound care; however, the costs described below are given for a selection of dressings in the NHS Supply Chain Catalogue.
Table 1 NHS Supply Chain Catalogue, cost of dressings for chronic wounds
|
Contact layers |
Cost of dressing |
Size of dressing |
|
Urgotul |
£3.20 |
10 cm × 10 cm |
|
Atrauman AG (silver layer) |
£1.37 |
10 cm × 10 cm |
|
Bactigras (antimicrobial) |
£0.54 |
10 cm × 10 cm |
|
Activon Tulle Advancis (antimicrobial, honey) |
£3.03 |
10 cm × 10 cm |
|
Solvaline N (knitted viscose) |
£0.20 |
10 cm × 10 cm |
|
Jelonet (paraffin) |
£0.30 |
10 cm × 10 cm |
|
Mepitel One |
£3.51 |
9 cm × 10 cm |
|
Acticoat Flex 3 (antimicrobial, silver) |
£8.89 |
10 cm × 10 cm |
|
Other foam dressings |
||
|
Tegaderm Foam |
£1.99 |
10 cm × 10 cm |
|
Advazorb |
£1.15 |
10 cm × 10 cm |
|
Mepilex foam silicone |
£2.94 |
10 cm × 11 cm |
Resource consequences
EpiFix would be a significant additional cost to standard care. If treatment resulted in higher healing rates, the additional costs could be offset by reduced use of dressings and chronic wound-care services and by avoiding future complications such as lower limb amputation. Staff may need training on the correct application of EpiFix. EpiFix is currently used in 1 NHS wound-care centre.