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

NCT ID: NCT00945152

Last Updated: 2022-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-15
• Study Completion Date: 2024-12-15

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.

Conditions

Bacterial Infections; Wounds

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Drug Vancogel,Treatment,Kill MRSA,Heal

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

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

Group Type: PLACEBO_COMPARATOR

Placebo, complex gel formulation without Vancomycin

Intervention Type: DRUG

Complex gel formulation applied as the placebo and is unknown because of the trial design. Complex gel formulation without Vancomycin

Interventions

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.

Intervention Type: DRUG

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

Intervention Type: DRUG

Other Intervention Names

Vancogel (R)# 77708836/Trademark issued 12-11-2012 Patent issued 02-02-2016 # 9248159; Topical MRSA Bactericidal Gel; Vancomycin complex gel formulation; Safgel

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Robert S Berman MD

OTHER

Sponsor Role: lead

Responsible Party

Robert S Berman MD

Sponsor-Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Robert S Berman, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

Robert S Berman MD /661 Maplewood Drive #21

Jupiter, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Robert S Berman, MD

Role: CONTACT

bermanmd@comcast.net

561-628-0040

Facility Contacts

Robert S Berman, MD

Role: primary

bermanmd@comcast.net

561-628-0040

Other Identifiers

None yet, self funding

Identifier Type: -

Identifier Source: secondary_id

WIRB study # 1111446

Identifier Type: -

Identifier Source: org_study_id