Effects of MRSA Bactericidal Gel To Promote Healing and Eliminate MRSA in cSSTI Vancogel(TM)
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease, Hospital |
| Therapuetic Areas: | Immunology / Infectious Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/9/2018 |
| Start Date: | July 2011 |
| End Date: | December 2019 |
| Contact: | Robert S Berman, MD |
| Email: | bermanmd@comcast.net |
| Phone: | 561-743-5197 |
Topical MRSA Bactericidal Gel to Eliminate MRSA and Promote Accelerated Healing of cSSTI of Open Wounds
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.
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.
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.
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.
We found this trial at
1
site
Jupiter, Florida 33477
Principal Investigator: Robert S Berman, MD
Phone: 561-743-5112
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