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

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 improved 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 calcium alginate gel formulation Drug: Vancomycin 1.25-1.5% compounded with a complex calcium alginate gel	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) 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:

MedlinePlus related topics: Bacterial Infections Calcium

Drug Information available for: Calcium Gluconate Vancomycin Vancomycin hydrochloride

U.S. FDA Resources

Further study details as provided by Robert S Berman MD:

Primary Outcome Measures:

Eliminate MRSA infection [ Time Frame: One week ] [ Designated as safety issue: No ]
Cultures taken prior to treatment and after.

Secondary Outcome Measures:

More rapid healing of cSSTI [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
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 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Drug Vancogel,Treatment,Kill MRSA,Heal Treatment of open wounds with Vancogel 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 gel and will have conventional management in order to heal the wound. Vancogel is anticipated to accelerate wound healing by eliminating MRSA.	Drug: Vancomycin 1.25-1.50% in a complex calcium alginate gel formulation Topical use for open wounds culturing out MRSA. One to three applications of the compound.in a weeks time. Other Names: Vancogel (TM)# 77708836/ Patent Pending # 12236246 Topical MRSA Bactericidal Gel Vancomycin compex calcium alginate gel formulation Drug: Vancomycin 1.25-1.5% compounded with a complex calcium alginate gel Vancomycin compounded with a complex calcium alginate gel to a concentration of 1.2-1.5% for topical use only.Applied 3 times in one week.

Arms

Assigned Interventions

Experimental: Drug Vancogel,Treatment,Kill MRSA,Heal

Treatment of open wounds with Vancogel 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 gel and will have conventional management in order to heal the wound. Vancogel is anticipated to accelerate wound healing by eliminating MRSA.

Drug: Vancomycin 1.25-1.50% in a complex calcium alginate gel formulation

Topical use for open wounds culturing out MRSA. One to three applications of the compound.in a weeks time.

Other Names:

Vancogel (TM)# 77708836/ Patent Pending # 12236246
Topical MRSA Bactericidal Gel
Vancomycin compex calcium alginate gel formulation

Drug: Vancomycin 1.25-1.5% compounded with a complex calcium alginate gel

Vancomycin compounded with a complex calcium alginate gel to a concentration of 1.2-1.5% for topical use only.Applied 3 times in one week.

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 over a 33 month time frame. The microbiological and HPLC studies are completed at present and approved. I am looking foreword to start the phase 2 studies on August 1,2011 as authorized by the FDA on June 22,2011.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received:	July 22, 2009
Last Updated:	November 3, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Robert S Berman MD:

Elimination of MRSA in open wounds
MRSA infected open wounds

Additional relevant MeSH terms:

Bacterial Infections
Alginic acid
Calcium, Dietary
Vancomycin
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

Pharmacologic Actions
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 16, 2013