INFECTION PREVENTION & WOUNDCARE
Dr David Chapman-Jones, Director of Science and Medicine at Synapse Microcurrent, explains the company’s single- use Accel-Heal treatment.
A
ccel-Heal is a stand alone sealed unit delivering a pre- programmed micro-current treat- ment. It is a single-use, single pro- gram medical device which incor- porates Synapse’s patented micro- current technology.
It facilitates
an accelerated rate of healing in all wounds, particularly complicated and diffi cult to heal ulcers.
Accel-Heal carries the CE mark having been tested and approved by Notifi ed Body 0120. It is certi- fi ed as a Class IIA device under the medical directive 93/42/EEC and has full Medical Devices Directive approval under ISO 13485:2003 es- tablishing safety and approval to be sold in European markets.
The unit is designed to be used in conjunction with any recom- mended wound dressing and as an adjunct to the prescribed wound management. It has been shown to dramatically reduce oedema, pain and improve wound repair. Previ- ous clinical trials have been focused on treating non-healing venous leg ulcers. The latest clinical trial showed that 38% of hitherto non- healing LVUs measuring less than 15cm2 weeks1
Ulcer Type Venous Leg Ulcer Poorly healing Venous Leg Ulcer
Poorly/Non healing Venous Leg Ulcer
Pressure Ulcer < three months duration <12cm2 Other complicated ulcer >10cm2 - 20cm2 >20cm2 <12cm2
nifi cant progress towards healing. In addition, a signifi cant reduction in oedema and pain was noted in 95% of the cohort.2
healed to full closure with 19 and larger VLUs showed sig-
Following a successful tender pro- cess with the North West Region Innovation Framework Agreement process with Shared Business Ser- vices (formerly North West Collab- orative Commercial Agency), Syn- apse Microcurrent Ltd embarked upon a “Pledge to Trial” (PTT) cam- paign. The purpose of the PTT cam- paign was to introduce Accel-Heal
Wound Size <10cm2 Accel Heal Treatment Duration
6 x Accel-Heal® units - 12 days treatments
>10cm2 - 30cm2
Accel-Heal® application until the wound reaches 50% of its original size
Accel-Heal® application until the wound reaches 50% of its original size
6 x Accel-Heal® units - 12 days treatments
For all smaller ulcers < 15cm2 6 x Accel-Heal® units, for
larger ulcers > 15cm2 - 30cm2 Accel-Heal® application until the wound reaches 50% of its original size
58 | national health executive Sep/Oct 11
Wound closure within 8 weeks
Wound closure within 20 weeks
Significant healing to wound closure within 26 weeks
Wound closure within 8 weeks
For all smaller ulcers < 15cm2 wound closure within 8 weeks
Ulcers > 15cm2 - 30cm2 wound closure within 20 weeks
to the clinical environment in a less formal setting than a tightly con- trolled and regulated clinical trial.
Tissue Viability Nurse (TVN) Feedback to PTT
One individual coordinated the PTT campaign and the following experi- ences were noted. Despite being presented with peer viewed pub- lished evaluations of Accel-Heal’s effi cacy, in general TVNs appeared guarded and reluctant to commit to purchase Accel-Heal without fi rst
Expected Outcome
trialling it on a number of ‘their’ pa- tients and experiencing for them- selves that a product ‘works’. This is why the PTT was launched.
However, when there was a willing- ness to immediately purchase there was a number of practical restraints that either prevented or made this process diffi cult.
For example, when treatments are not on the Primary Care Trusts For- mulary and when a new purchase had to be charged from an existing allocated departmental budget (a typical Accel-Heal treatment pro- gramme costs £240. Each single device costs £40 with an average six units being used for wounds un- der 15cm2
).
Accel-Heal was not available on FP10 which also stopped TVNs from using the product.
One signifi cant practical diffi culty for the PTT coordinator was TVNs’ availability for an initial meeting. With some hospitals or PCTs, hav- ing one TVN resulted in them being extremely busy.
Accel-Heal is an adjunct therapy that is used in conjunction with compression bandaging which was welcomed by TVNs as current clinical practice did not have to be modifi ed.
However, the PTT coordinator
supported each PTT centre by at- tending clinics when patients were started on the Accel-Heal treat- ment. In addition, district nurses involved in PTT were sometimes met at the patients home.
The feedback received by the PTT coordinator from the TVNs specifi c to Accel-Heals’s effi cacy was: • It is quick and easy to apply • It works under compression bandaging, in association with current wound care management • The patients could not feel
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