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

Study Overview
=================
Brief 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.

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.

Official Title
-----------------
Topical MRSA Bactericidal Gel to Eliminate MRSA and Promote Accelerated Healing of cSSTI of Open Wounds

Conditions
-----------------
Bacterial Infections, Wounds

Intervention / Treatment
-----------------
* Drug: Vancomycin 1.25-1.50% in a complex gel formulation trademarked Vancogel(R)
* Drug: Placebo, complex gel formulation without Vancomycin


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug Vancogel,Treatment,Kill MRSA,Heal<br>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)<br>* 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.<br>* Other names: Vancomycin complex gel formulation;|
| Placebo Comparator: Placebo<br>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<br>* Complex gel formulation applied as the placebo and is unknown because of the trial design. Complex gel formulation without Vancomycin<br>* Other names: Safgel;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eliminate MRSA infection | Cultures taken during and prior to treatment and after. | One week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| More rapid healing of cSSTI | The effects of the MRSA bactericidal gel will accelerate wound healing by eliminating the infection in cSSTI wounds | 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Elimination of MRSA in open wounds, MRSA infected open wounds