Direct Antibiotic Delivery of Cefazolin Into Soft Tissue Infections Using Subcutaneous Injection and Ultrasonic Dispersion (DAD)
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|ClinicalTrials.gov Identifier: NCT01238276|
Expanded Access Status : No longer available
First Posted : November 10, 2010
Last Update Posted : October 23, 2018
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|
- Drug: Cefazolin
Cefazolin is approved for clinical use for some bacterial infections. The standard routes of administration are Intramuscular (IM) and intravenous (IV). For this study, the route of administration will be delivered using the Silberg TPS, which delivers the cefazolin by subcutaneous injection followed by external ultrasonic dispersion. The concentration delivered is one gram/100 ml saline. Cefazolin can safely be given IM at the much higher concentration of 1 gram/2.5 ml of saline. The maximum dose that may be administered is 3 grams in 300 ml, which is within the approved guidelines of a daily dose. The concentration of antibiotic will be the same; only the dose may vary depending on the size of the wound or area of induration. Each subject will receive only one treatment in this study.Other Names:
- Device: Silberg Tissue Preparation System
The TPS is FDA cleared 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.Other Names:
- Silberg TPS (K023083)
- Tissue Preparation System
- Mettler ME800
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|