Effects of MRSA Bactericidal Gel To Promote Healing and Eliminate MRSA in cSSTI Vancogel(TM)

Last updated: July 19, 2022
Sponsor: Robert S Berman MD
Overall Status: Active - Recruiting

Phase

2

Condition

Bacterial Infections

Wounds

Treatment

N/A

Clinical Study ID

NCT00945152
WIRB study # 1111446
None yet, self funding
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • MRSA infected open wounds
  • Acute and chronic wounds
  • Type of wounds: venous stasis,diabetic, pressure, post surgical, post traumatic, andspontaneous
  • 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

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.

Study Design

Total Participants: 100
Study Start date:
July 15, 2011
Estimated Completion Date:
December 15, 2024

Study 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.

Connect with a study center

  • Robert S Berman MD /661 Maplewood Drive #21

    Jupiter, Florida 33458
    United States

    Active - Recruiting

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