Proof of principle: rapidly removing biofilm and necrosis in hard to heal ulcers using a hygroscopic chemical compound.

Introduction:
The chronicity of hard-to-heal lesions is caused and sustained by a number of factors, including the development and presence of biofilm, which contributes significantly to the (hyper) inflammation which, in turn, causes these lesions to stall. Prevention and removal of biofilm is, therefore, an important step to getting these types of wounds to heal. Surgical intervention is an effective way to serve this goal but is complicated, expensive, and not always possible.

Study material:
A new chemical compound was tested in more than 100 consenting patients in an IRB approved proof of principle study. The chemical compound has a strong hygroscopic action, leading to virtually immediate desiccation of tissue and microorganisms by instantly capturing water molecules in microorganisms and tissues. This mode of action leads to rapid dissolution of the biofilm and necrosis which is hypothesized to assist in fast development of granulation tissue and subsequent reepithelialization. 

Clinical results:
Four representative cases are demonstrated, one non-healing post-traumatic lesion on the right lateral malleolus, one non-healing diabetic foot ulcer and two stalled venous leg ulcers. All large lesions were covered with necrosis and showed clinical signs of the presence of biofilm, had been in existence for prolonged periods and had been previously treated with a significant number of different modalities without substantial healing results. In all patients, one application of the compound was enough to remove the biofilm and necrosis and all lesions proceeded to granulation and subsequent reepithelialization without any interventions other than regular dressing changes with Vaseline gauze.  

Conclusion:
The cases presented here indicate that the new chemical compound has the potential to remove biofilm and necrosis very rapidly and efficiently, thus increasing the chance of healing of stalled wounds. A multicenter, randomized comparative clinical trial versus surgical intervention is currently being conducted to confirm these observations.

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