Direct Antibiotic Delivery of Cefazolin Into Soft Tissue Infections Using Subcutaneous Injection and Ultrasonic Dispersion (DAD)
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.
Infection, Soft Tissue
Foot Ulcer, Diabetes
Device: Silberg Tissue Preparation System
|Study Type:||Expanded Access What is 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 (Final data collection date for primary outcome measure)|
- Silberg TPS (K023083)
- Tissue Preparation System
- Mettler ME800
The TPS is FDA approved for the subcutaneous infusion and ultrasonic dispersion of tumescent fluid excluding the parenteral delivery of drugs. Under this study, the TPS is a device to deliver cefazolin by subcutaneous injection followed by external ultrasonic dispersion. The TPS consists of a medical grade peristaltic pump that is used to infuse antibiotic solution using a sterile blunt-tipped infusion cannula into a superficial subcutaneous plane. After the cannula has been removed, high frequency external ultrasound is delivered transcutaneously over the area of infusion in order to disperse the antibiotic solution. The power density is within the range allowed for physical therapy.
Delivering a higher concentration of antibiotic directly into the infected soft tissues independent of blood supply allows a significantly greater concentration of antibiotic to be delivered to the target tissues than can be achieved by any other method.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01238276
|Contact: Barry N Silberg, M.D.||email@example.com|
|Contact: Michele Brule, MBAfirstname.lastname@example.org|
|United States, California|
|Santa Rosa, California, United States, 95403|
|Contact: TBD , M.D.|
|Principal Investigator: Barry N Silberg, MD, FACS|
|Principal Investigator:||Barry N Silberg, MD||Palm Drive Hospital, Santa Rosa Memorial Hospital, Sutter Health|
|Study Director:||Roger A Klein, MD||TBD|