Direct Antibiotic Delivery of Cefazolin Into Soft Tissue Infections Using Subcutaneous Injection and Ultrasonic Dispersion (DAD)
|ClinicalTrials.gov Identifier: NCT01238276|
Recruitment Status : Temporarily not available
First Posted : November 10, 2010
Last Update Posted : August 16, 2016
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.
|Condition or disease||Intervention/treatment|
|Infection, Soft Tissue Infection, Wound Cellulitis Diabetic Foot Ulcer||Drug: Cefazolin Device: Silberg Tissue Preparation System|
In this study, the DOSAGE of cefazolin that is delivered is a fraction of that which is already FDA approved for intramuscular (IM) administration. However, the CONCENTRATION in the target area is much higher than what can be achieved through intravenous (IV) administration, while still being far less than what is approved for IM administration.
Previous to this study, cefazolin was considered to be ineffective in treating Methicillin-resistant Staphylococcus aureus (MRSA) as it had only been tested at the concentrations that were attainable by traditional methods. Through our study and laboratory tests conducted at the Harford Hospital, Connecticut, we have confirmed that cefazolin can be effective against even the most resistant strains of MRSA if a high enough concentration is obtained.
Under this study, treatment is only available to subjects that have already undergone standard therapy, but were not able to resolve the infection.
|Study Type :||Expanded Access|
|Official Title:||Direct Antibiotic Delivery of Cefazolin Into Soft Tissue Infections Using Subcutaneous Injection and Ultrasonic Dispersion|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||December 2015|
- Silberg TPS (K023083)
- Tissue Preparation System
- Mettler ME800
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01238276
|United States, California|
|Sonoma West Medical Center|
|Sebastopol, California, United States, 95472|
|Principal Investigator:||Barry N Silberg, MD||Sonoma West Medical Center, Santa Rosa Memorial Hospital, Sutter Health|
|Study Director:||James K Gude, MD||Sonoma West Medical Center|