Vancogel(R)
Topical MRSA Bactericidal Gel to Eliminate MRSA and Promote Accelerated Healing of cSSTI of Open Wounds
Sponsor study identifier
Secondary identifiers
interventional
100
1 country
1
Study Start
July 15, 2011
Actual (reported)Primary Completion
December 15, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 15, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 15, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 22, 2009
Actual (reported)July 23, 2009
Actual (reported)July 15, 2011
Actual (reported)December 15, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 15, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Eliminate MRSA infection
Cultures taken during and prior to treatment and after.
One week
More rapid healing of cSSTI
3 weeks
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.
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
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.
Robert S Berman MD /661 Maplewood Drive #21
Jupiter, Florida, 33458, United States
Robert S Berman, MD
First Submitted
July 22, 2009
First Posted
July 23, 2009
Study Start
July 15, 2011
Actual (reported)Primary Completion
December 15, 2024
Estimated (date passed)Study Comparing the Safety and Efficacy of Two Doses of BC-3781 vs Vancomycin in Patients With Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
Complex gel formulation applied as the placebo and is unknown because of the trial design. Complex gel formulation without Vancomycin
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 15, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 21, 2022
Record last verified: 2022-07
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