Feasibility,Safety,and Primary Efficacy of DermaStream

Abstract

Chronic wounds are associated with significant morbidity, mortality, and economic burden. Once a wound has settled into a senescent phase, outside factors must be used to convert that wound back to a more acute phase. Traditional methods, such as surgical debridement or biologic debridement, can cause removal of healthy tissue as well as pain to the patient. Enzymatic debridement has been under much scrutiny lately as popular drugs have been pulled by the Food and Drug Administration. The purpose of this study was to test feasibility, safety, and primary efficacy of 5 control subjects and 10 treatment subjects to the DermaStream system. It is a device that uses a continuously streaming infusion to create a stable, granular wound bed in a relatively short amount of time. The device provides for continuously streaming of therapeutic solutions to the wound while removing exudates by vacuum-assisted drainage throughout the treatment cycle.