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

Robert S Berman MD

Status and phase: Enrolling; Phase 2

Conditions: Wounds; Bacterial Infections

Treatments: Drug: Vancomycin 1.25-1.50% in a complex gel formulation trademarked Vancogel(R); Drug: Placebo, complex gel formulation without Vancomycin

Study type: Interventional

Funder types: Other

Identifiers

NCT00945152

WIRB study # 1111446

None yet, self funding

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Drug Vancogel,Treatment,Kill MRSA,Heal

Experimental group

Description:

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.

Treatment:

Drug: Vancomycin 1.25-1.50% in a complex gel formulation trademarked Vancogel(R)

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo, complex gel formulation without Vancomycin