Full Clinical Study Initiated Following Success with 8 Patients
PRINCETON, N.J., May 13 /PRNewswire-FirstCall/ -- Derma Sciences (OTC Bulletin Board: DSCI), a provider of advanced wound care products, today announced that a group of cardiovascular and thoracic surgeons from the University of Wurzburg, Germany, have used MEDIHONEY(TM) dressings to successfully treat 8 patients with deep sternal wound infections (DSWI), a condition that sometimes arises after open-heart surgeries. The dressings were used in combination with V.A.C.(R) Therapy (KCI, San Antonio, Texas), the largest and fastest growing technology in advanced wound care. Based on the successful results of this observational study, the researchers have initiated a prospective, randomized, controlled study on the influence of MEDIHONEY on the treatment of DSWI.
Derma Sciences CEO Ed Quilty stated, "The results from this initial 8-patient study are very encouraging. DSWI adds significant additional hospitalization costs to median sternotomy and coronary artery bypass grafting (CABG) procedures, and also significantly increases mortality rates in these patients. We believe the addition of MEDIHONEY to these expensive procedures will provide clinicians a cost-effective way to improve outcomes. Additionally, the recent increase in CABG procedures, due to efficacy concerns over less invasive forms of surgery and drug-eluting stent procedures, makes this an attractive and growing target market."
Quilty went on to say, "Use of the V.A.C. in post-surgical applications -- including DSWI -- has been steadily increasing. Overall, this product generates over $1 billion in revenues globally, and is the first true blockbuster in the field of wound care. Gaining acceptance as an adjunct to this therapy will add significantly to the global usage of MEDIHONEY."
The study was published in the proceedings of the 5th Annual Joint
Meeting of the German, Austrian, and Swiss Societies for Cardiovascular and
Thoracic Surgery as a special publication of the Journal of the Thoracic
and Cardiovascular Surgeon. The investigators reported that there were no
local or systemic adverse reactions to the treatment and that all patients
progressed to complete wound healing. In the six patients who received
application of MEDIHONEY every four days, the wounds were clean and sterile
after a mean duration of treatment of 23 days. The two patients that
received fewer applications of MEDIHONEY showed repeat positive wound
cultures. No nosocomially acquired "superinfections" (including MRSA and
VRE) were seen.
To read the abstract, please go to: http://www.thieme-connect.com/ejournals/abstract/thoracic/doi/10.1055/s-2008-1038073 (Information in this article concerns a use that has not been cleared by the US Food and Drug Administration.)
About deep sternal wound infections
Deep sternal wound infections occur in roughly 0.8% to 2% of patients undergoing median sternotomy and CABG. This rate increases to as high as 5.6% for diabetic patients, who make up between 17% and 20% of all patients undergoing CABG surgery. DSWI is associated with an average hospital stay increase of 16 days (average cost of over $25,000) and a higher mortality rate (19% versus 3.8% in patients without infection). Although the number of CABG procedures had been in decline since 2000 due to the advent of percutaneous coronary interventions (PCI) and drug-eluting stent (DES) procedures, recent questions into the safety and efficacy of these procedures has led to a 0.9% growth in CABG procedures. Approximately 800,000 to 1 million CABG procedures are performed globally each year. The worldwide CABG market is roughly $36 billion.
About Derma Sciences
Derma Sciences is a global manufacturer and marketer of advanced
wound-care products. Its key product, MEDIHONEY, is sold throughout the
world by Derma Sciences and Comvita New Zealand -- the licensor of the
patented honey-based technology -- and is the leading brand of honey-based
dressings for the management of wounds and burns. The product has been
shown to be effective in a variety of wounds and burns, and was recently
the focus of a large scale randomized controlled trial on leg ulcers. For
more information about Derma Sciences, Inc., visit its home page on the
Internet at http://www.dermasciences.com.
Contact: Derma Sciences Inc Allen & Caron Inc
Edward J. Quilty Rudy Barrio (US Investors)
Chairman and CEO email@example.com
(609) 514-4744 Brian Kennedy (media)
|SOURCE Derma Sciences|
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