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

Bacterial Infections Clinical Trial

— Vancogel(R)  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00945152
• Other study ID #: WIRB study # 1111446
• Secondary ID: None yet, self f
• Status: Recruiting
• Phase: Phase 2
• Start date: July 15, 2011
• Est. completion date: December 15, 2024

Study information

• Verified date: July 2022
• Source: Robert S Berman MD
• Contact: Robert S Berman, MD
• Phone: 561-628-0040
• Email: bermanmd[@]comcast.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 15, 2024
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bacterial Infections
• Wounds

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	Robert S Berman MD /661 Maplewood Drive #21	Jupiter	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Robert S Berman MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eliminate MRSA infection	Cultures taken during and prior to treatment and after.	One week
Secondary	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