Electric stimulation wound dressing

NewsBot · Oct 10, 2006

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Press Release:
Biofisica receives European clearance for first electric stimulation wound dressing
9 October 2006

Atlanta, USA. Biofisica LLC, a medical device start-up company based in Atlanta, Georgia, has received clearance to market its POSiFECT RD bio-electric wound care product in Europe. Biofisica worked with the British Standards Institute (BSI) throughout the conformity assessment process and has received clearance to affix the European CE Mark to its product.

The company plans to launch its wound care product in the UK within the next three months, followed by staged rollouts in France, Germany and the Nordic region. POSiFECT RD (RD refers to the dressing's round shape) is the first device available that combines two technologies — moist wound-care dressing and electrical stimulation — in a disposable, easy-to-use, sterile dressing that facilitates the normal healing process. Early clinical research has shown that POSiFECT demonstrates healing in many difficult to heal or non-healing wounds.

"We are delighted to have received marketing authorization for POSiFECT, and can now begin to provide this pioneering therapeutic option to tissue viability nurses (TVNs) throughout the UK for the care of their patients," said Rafael Andino, president of Biofisica. "It is intensely satisfying — at both personal and professional levels — to develop a technology that has such a positive impact on patients' lives and has the potential to help heal non- healing chronic wounds instead of simply 'managing the wound' as other products do."

Bio-electric stimulation therapy

The company says that POSiFECT RD bio-electric stimulation therapy is indicated for the management of chronic wounds where conventional therapies have failed. It is designed for use on chronic ulcerated wounds; including venous leg ulcers, pressure ulcers and diabetic foot ulcers.

Patient groups especially prone to these conditions are the elderly, immobile patients and individuals suffering from diabetes. The dressing contains a miniature electrical circuit that delivers a microcurrent to the wound bed. This microcurrent is derived from non-rechargeable coin cell batteries. The dressing remains on the wound for 48 hours and is then replaced with a new dressing.

Clinical studies have shown that when using POSiFECT on difficult to heal chronic wounds, tissue regeneration at the wound bed site occurs within a few weeks.

The process of tissue repair is dynamic and complicated. All living tissue in the human body possesses endogenous bio-electric circuits that contribute to healing once a wound is created. However, with long-term chronic wounds, the body's natural ability to create these "currents of healing" is compromised. Biofisica's breakthrough bio-electric technology associated with POSiFECT, dovetails with normal tissue repair by stimulating the wound bed as would the body's own "current of healing."
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Jbwheele · Oct 12, 2006

Can I find out more?

Hi.

What are the clinical studies, are they available for study?
How much ?
Cost / Benefit over other dressings ?

........Anyone?

Cheers

Joe

admin · Oct 12, 2006

POSiFECT

There are a few abstracts and cases floating around, but nothing definitive. Check Google

NewsBot · Jul 29, 2009

A new electrode design to improve outcomes in the treatment of chronic non-healing wounds in diabetes.
Suh H, Petrofsky J, Fish A, Hernandez V, Mendoza E, Collins K, Yang T, Abdul A, Batt J, Lawson D.
Diabetes Technol Ther. 2009 May;11(5):315-22.

BACKGROUND: Chronic wounds are life-threatening in people with diabetes. Some studies show that electrical stimulation (ES) can help wounds heal, while others do not. But, ES is usually applied using a two-electrode system, where current distribution is greatest in the center line between the electrodes. In the present study, a three-electrode system (three-channel ES) was developed. Current dispersion on the skin and in the quadriceps muscle was compared between the conventional two-electrode and three-electrode systems in controls and tested for its ability to heal chronic wounds in people with diabetes.

METHODS: In controls, current was delivered via a biphasic sine wave at a frequency of 30 Hz and pulse width of 100 microseconds. Stimulation electrodes 5 cm x 5 cm and 5 cm x 10 cm were placed at 10 cm and 15 cm separation distances above the quadriceps muscle. Skin currents were measured using five pairs of surface electrodes positioned in five separate locations on the skin. Muscle currents were measured using three pairs of needle electrodes positioned in three different locations in the muscle belly. In chronic wounds in eight subjects with diabetes, stimulation was applied for 1 month, and healing and blood flow were measured.

RESULTS: Current during three-channel ES was dispersed more evenly and more deeply than with conventional two-channel ES (P < 0.05). In wounds, there was almost complete healing in 1 month, and current was uniform in the wound.

CONCLUSIONS: Three-channel ES is more effective than two-channel ES in terms of better current dispersion across the skin and penetration into tissue and will probably be better for wound healing.
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