Start of clinical trial for Bayer’s new silica gel wound dressing

New hope in treatment of chronic wounds

Leverkusen. They say that time heals all wounds. Unfortunately, this is not true. Many people have serious wounds which heal only very slowly, if at all. For chronic wounds such as this, Bayer Innovation GmbH (BIG) has developed a special wound dressing which is designed to speed up the healing process.
A first clinical trial in patients suffering from chronic venous leg ulcers is now starting at the University Hospitals of Cologne and Hamburg. These patients are being treated with the novel wound dressing.
Rapid healing: wound dressings made from novel materials ensure that chronic wounds heal more quickly.
In the second half of the year, the trial will then be extended to 15 hospitals in Europe and the United States with a total of 250 patients. For BIG, the start of the trial is an important milestone. “It is the first project we have taken into a clinical trial,” says Dr. Detlef Wollweber, Managing Director of BIG. Equally gratifying, adds Wollweber, is that, “We’ve achieved this after just three years of our own development time.” The trial is designed to show whether Bayer’s new wound dressing promotes the healing process in chronic wounds. “For this, half of the participants will be treated with our new product, while the remaining patients will receive a conventional dressing,” explains Iwer Baecker, Project Manager at BIG. The healing process will then be evaluated at defined intervals. There are great hopes that Bayer’s new development will be able to help fill a large treatment gap.
 
The Professional Association of German Surgeons [Berufsverband deutscher Chirurgen] estimates that there are between two and four million patients in Germany have to cope with poorly healing, often painful wounds. These include people with a diabetic foot or with certain vascular diseases, for example. Elderly patients in particular often have to deal with chronic wounds. Thanks to its silica gel fibers, Bayer’s new wound dressing actively supports the natural healing process. Studies have already shown that the material, which was awarded the Josef von Fraunhofer Prize for research in 2008, could provide ideal conditions for healing.
 
The textile fibers apparently provide healthy cells with an ideal structure to which they can adhere, enabling new skin layers to form rapidly along the fibers of the dressing. "The market was previously lacking a product which actively supports the healing process in this way,” comments Professor Sabine Eming from the Department of Dermatology at the University of Cologne, principal investigator of the trial. Another advantage is that the silica gel fibers are broken down by the body over time. It is therefore not necessary to remove the wound dressing. All that remains in the end is the newly formed skin, which seals the wound. The trial is scheduled to be completed in 2011. “However, we hope to be able to estimate the commercial prospects of this kind of product well before on the basis of initial interim results, and we will make preparations accordingly,” says Baecker. BIG is supported by experts at Bayer HealthCare, Bayer Schering Pharma and Bayer Vital. Colleagues from Bayer Technology Services and Currenta are also cooperating, for example with the production of the wound dressing samples and also with analysis. According to BIG Managing Director, Wollweber, “This project is a good example of how synergies between the different subgroups and service companies can be exploited.”
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