Uluru Initiates First Clinical Study Using Altrazeal Silver
Uluru, a specialty pharmaceutical company, has started a clinical study to evaluate patients with graft donor sites treated with Altrazeal silver compared with silver containing carboxymethylcellulose dressing.
The study will be conducted at four clinical sites with 40 evaluable patients being enrolled. The first study site has been initiated and the company plans to initiate additional sites within the next 30-days.
Each patient will have two skin graft donor sites, with Altrazeal Silver being applied to one site and the competitive dressing being applied to the other site. The primary study objective is to evaluate wound healing. Secondary study objectives include evaluating the incidence of wound infection, number of dressing changes, patient pain and provider and patient satisfaction.
This study is designed to support the marketing of Altrazeal Silver and provide the necessary clinical data to apply for a CE Mark which will enable Altrazeal silver to be marketed in Europe and Canada.
The company’s strategy is to develop a range of Altrazeal products incorporating active compounds for the treatment of the various phases of wound healing, infection, inflammation, debridement, maturation and closure. Altrazeal Silver will be the first product to demonstrate execution of this strategy.
Renaat Hooff, executive vice president of operations at Uluru, said: “Silver containing dressings are used extensively in the skin graft donor site indication to protect against infection. With the use of silver containing dressings increasing in both chronic wounds and burns, this product line extension is an important component of our wound care franchise.”