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| ID | Type | Description | Link |
|---|---|---|---|
| None yet, self funding |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug Vancogel,Treatment,Kill MRSA,Heal | Experimental | Treatment of open wounds with Vancogel(R) 1.25-1.50% to eliminate MRSA. End point is: a negative culture report after 1-3 topical applications. The infected wounds with MRSA will be treated with the Vancomycin 1.25 to 1.50% complex gel formulation and will have conventional management in order to heal the wound. Vancogel is anticipated to accelerate wound healing by eliminating MRSA. A randomized, double blind study protocol approved by FDA. |
|
| Placebo | Placebo Comparator | Half of the patients in the study will be given a placebo consisting of all ingredients in Vancogel except the active principal Vancomycin in order to compare their clinical efficacy in rate of wound healingafter 1-3 applications |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vancomycin 1.25-1.50% in a complex gel formulation trademarked Vancogel(R) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Eliminate MRSA infection | Cultures taken during and prior to treatment and after. | One week |
| Measure | Description | Time Frame |
|---|---|---|
| More rapid healing of cSSTI | The effects of the MRSA bactericidal gel will accelerate wound healing by eliminating the infection in cSSTI wounds | 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert S Berman, MD | Contact | 561-628-0040 | bermanmd@comcast.net |
| Name | Affiliation | Role |
|---|---|---|
| Robert S Berman, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert S Berman MD /661 Maplewood Drive #21 | Recruiting | Jupiter | Florida | 33458 | United States |
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| Placebo, complex gel formulation without Vancomycin | Drug | Complex gel formulation applied as the placebo and is unknown because of the trial design. Complex gel formulation without Vancomycin |
|
|
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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