Bacterial Infections, Wounds
Conditions
Keywords
Elimination of MRSA in open wounds, MRSA infected open wounds
Brief summary
Based on personal experience and the literature it is reasonable expectation that Vancomycin is a viable treatment in a direct contact form to eliminate MRSA from open wounds in order to heal the wounds by conventional means. The key question in my research has been to measure the effectiveness of my Vancomycin Gel by culturing the wound, applying the Gel in a controlled manner and then culturing the wound after one week. The end point to achieve in the process, is a clinical response of accelerated healing and negative culture report. Another question to solve is the duration of potency and stability of the Vancomycin gel over time.
Detailed description
Over a prior preliminary 33 month study I have found negative cultures at the end of one week of treatment and have had microbiological studies establishing the same MIC zones in culture media greater than 15mm over a 33 month time frame. The microbiological and HPLC studies are completed at present and approved. I have started the phase 2 studies on August 1,2011 as authorized by the FDA on June 22,2011.
Interventions
DRUGVancomycin 1.25-1.50% in a complex gel formulation trademarked Vancogel(R)
Topical use for open wounds culturing out MRSA. One to three applications of the compound over a weeks time. Consists of Vancomycin 1.25-1.50% in a complex gel formulation.
DRUGPlacebo, complex gel formulation without Vancomycin
Complex gel formulation applied as the placebo and is unknown because of the trial design. Complex gel formulation without Vancomycin
Sponsors
Robert S Berman MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* MRSA infected open wounds * Acute and chronic wounds * Type of wounds: venous stasis,diabetic, pressure, post surgical, post traumatic, and spontaneous * Infection criteria: Include a positive culture for MRSA * Location of ulcers: any place on the body * Diagnosis of MRSA: Based on tissue cultures of MRSA * Willing and reliable patients * Study to include only one ulceration no more than 50 square centimeters * The study to include stages two and three ulcerations
Exclusion criteria
* Non-compliant patients * Patient must accept all issues in consent form * Non compliance to include failed appointments * Wounds greater than 50sq. cm * No wounds deeper than soft tissue * Ischemic or vascular disease, dermatitis, immune deficiency,or psoriasis * Allergy to Vancomycin * Post irradiation ulceration * Bleeding disorders * Skin allergies to adhesives and tape * Ulcers related to cancers * Multiple wounds * Stage 4 ulcerations * Patients in any other trial * Patients with any other conditions which, in the opinion of the investigator/doctor, would preclude participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eliminate MRSA infection | One week | Cultures taken during and prior to treatment and after. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| More rapid healing of cSSTI | 3 weeks | The effects of the MRSA bactericidal gel will accelerate wound healing by eliminating the infection in cSSTI wounds |
Countries
United States
Contacts
Primary ContactRobert S Berman, MD
Outcome results
None listed