Direct Antibiotic Delivery of Cefazolin Into Soft Tissue Infections Using Subcutaneous Injection … (NCT01238276) | Clinical Trial Compass
NO_LONGER_AVAILABLENot Applicable
Direct Antibiotic Delivery of Cefazolin Into Soft Tissue Infections Using Subcutaneous Injection and Ultrasonic Dispersion
United States
Plain-language summary
This study focuses on a new drug delivery system (Direct Antibiotic Delivery) to treat soft tissue infections. In this study, cefazolin is delivered directly to the target tissues using subcutaneous injection of antibiotic solution and then dispersed using high-frequency external ultrasound. Using this system, a much higher concentration of antibiotic can be achieved than through traditional treatment methods.
Unlike traditional delivery methods, Direct Antibiotic Delivery does not rely on blood supply and is beneficial for subjects with Diabetes or subjects who have received radiation therapy and blood supply is limited.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Subjects with pathologically confirmed presence of serious or immediately life-threatening soft tissue infection, cellulitis or open wound caused by bacteria for which cefazolin at this concentration is likely to have activity to inhibit the bacteria, for example, Staphylococcus species or Streptococcus species, Escherichia coli, Proteus mirabilis.
* Wounds must demonstrate the presence of skin and skin structure infection, which may be demonstrated by one or more of the following: Culture results as aforementioned, swelling of the tissues, discoloration, open wounds, and/or drainage, which may or may not be associated with pain and/or tenderness.
* Confirmed presence of soft tissue cellulitis caused by bacteria for which cefazolin is likely to have activity to inhibit the bacteria will be evidenced by microbiologic cultures taken no greater than ten (10) days prior to treatment.
* Subject must have previously been treated by a qualified licensed physician using traditional surgical and/or medical treatments, which may include courses of IV antibiotics, but where Subject was unable to resolve their infection through traditional surgical and/or medical treatments for soft tissue cellulitis caused by bacteria for which cefazolin is likely to have activity to inhibit the bacteria at a maximum concentration of 1 gram per 100 ml saline, as demonstrated by the presence of induration, redness, open wounds, and/or soft tissue swelling.
* Subject must be referre…