Clinical trial NCT00945152: Effects of MRSA Bactericidal Gel To Promote Healing and Eliminate MRSA in cSSTI Vancogel(TM)
Official title: Topical MRSA Bactericidal Gel to Eliminate MRSA and Promote Accelerated Healing of cSSTI of Open Wounds
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Bacterial Infections
Wounds
Keywords: Elimination of MRSA in open wounds
MRSA infected open wounds
Lead sponsor: Robert S Berman MD
Sponsor class: OTHER
First posted: 2009-07-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Eliminate MRSA infection
timeFrame: One week
Secondary outcomes:
measure: More rapid healing of cSSTI
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Jupiter
country: United States
facility: Robert S Berman MD /661 Maplewood Drive #21
state: Florida
Study officials:
name: Robert S Berman, MD
role: PRINCIPAL_INVESTIGATOR
References: