Jupiter, Florida 33458

  • Wounds

Purpose:

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.


Study summary:

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.


Criteria:

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.


NCT ID:

NCT00945152


Primary Contact:

Principal Investigator
Robert S Berman, MD

Robert S Berman, MD
Phone: 561-628-0040
Email: bermanmd@comcast.net


Backup Contact:

N/A


Location Contact:

Jupiter, Florida 33458
United States

Robert S Berman, MD
Phone: 561-628-0040
Email: bermanmd@comcast.net

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 26, 2023

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.