Recruiting
Phase 2

Vancogel™

Sponsor:

Robert S Berman MD

Code:

NCT00945152

Conditions

Bacterial Infections

Wounds

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

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

Placebo, complex gel formulation without Vancomycin

Study Details

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.

Conditions

Bacterial Infections

Wounds

Study ID

NCT00945152

Start date

Jul 15, 2011

Status verified date

Jul, 2022

Completion date

Dec 15, 2024

Anticipated

Primary completion date

Dec 15, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

placebo comparator: 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

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.

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

Primary outcome measure

  • Eliminate MRSA infection [ Time Frame: One week ]

Central Contacts and Locations

Central contacts

Robert S Berman, MD

561-628-0040bermanmd@comcast.net

Locations

Robert S Berman MD /661 Maplewood Drive #21

Recruiting

Jupiter, Florida, United States, 33458

Contacts

Robert S Berman, MD

561-628-0040bermanmd@comcast.net

Principal Investigator:

Robert S Berman, MD

More Information

Sponsor

Robert S Berman MD

Last update posted

Jul 21, 2022

Last verified

Jul, 2022

Keywords

  • Elimination of MRSA in open wounds
  • MRSA infected open wounds

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Robert S Berman MD on 2022-07-21.