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

This study is currently recruiting participants.
Verified August 2017 by Robert S Berman MD
Sponsor:
ClinicalTrials.gov Identifier:
NCT00945152
First Posted: July 23, 2009
Last Update Posted: August 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Robert S Berman MD
  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.

Condition Intervention Phase
Bacterial Infections Wounds Drug: Vancomycin 1.25-1.50% in a complex gel formulation trademarked Vancogel(R) Drug: Placebo, complex gel formulation without Vancomycin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Topical MRSA Bactericidal Gel to Eliminate MRSA and Promote Accelerated Healing of cSSTI of Open Wounds

Resource links provided by NLM:


Further study details as provided by Robert S Berman MD:

Primary Outcome Measures:
  • Eliminate MRSA infection [ Time Frame: One week ]
    Cultures taken during and prior to treatment and after.


Secondary Outcome Measures:
  • More rapid healing of cSSTI [ Time Frame: 3 weeks ]
    The effects of the MRSA bactericidal gel will accelerate wound healing by eliminating the infection in cSSTI wounds


Estimated Enrollment: 100
Study Start Date: July 2011
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drug Vancogel,Treatment,Kill MRSA,Heal
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.
Drug: Vancomycin 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.
Other Names:
  • Vancogel (R)# 77708836/Trademark issued 12-11-2012 Patent issued 02-02-2016 # 9248159
  • Topical MRSA Bactericidal Gel
  • Vancomycin complex gel formulation
Placebo Comparator: Placebo
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
Drug: Placebo, 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
Other Name: Safgel

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00945152


Contacts
Contact: Robert S Berman, MD 561-743-5197 bermanmd@comcast.net

Locations
United States, Florida
Robert S Berman MD / 2141 Alt. A1A South, Suite 450 Recruiting
Jupiter, Florida, United States, 33477
Contact: Robert S Berman, MD    561-743-5112    bermanmd@comcast.net   
Principal Investigator: Robert S Berman, MD         
Sponsors and Collaborators
Robert S Berman MD
Investigators
Principal Investigator: Robert S Berman, MD
  More Information

Responsible Party: Robert S Berman MD, Sponsor-Investigator
ClinicalTrials.gov Identifier: NCT00945152     History of Changes
Other Study ID Numbers: WIRB study # 1111446
None yet, self funding
First Submitted: July 22, 2009
First Posted: July 23, 2009
Last Update Posted: August 30, 2017
Last Verified: August 2017

Keywords provided by Robert S Berman MD:
Elimination of MRSA in open wounds
MRSA infected open wounds

Additional relevant MeSH terms:
Bacterial Infections
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents