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Antibiotic

MRSA Bactericidal Gel for Wounds (Vancogel(R) Trial)

Phase 2

Recruiting

Led By Robert S Berman, MD

Research Sponsored by Robert S Berman MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Location of ulcers: any place on the body

Acute and chronic wounds

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 weeks

Awards & highlights

Vancogel(R) Trial Summary

This trial is testing whether Vancomycin can help heal open wounds by eliminating MRSA.

Who is the study for?

This trial is for patients with certain open wounds infected by MRSA, including venous stasis, diabetic, pressure, post-surgical or traumatic wounds. The wound must be stage two or three and no larger than 50 square centimeters. Participants need to have a positive culture for MRSA and be willing to follow the study procedures.Check my eligibility

What is being tested?

The trial tests Vancogel(TM), a gel containing Vancomycin (an antibiotic), against a placebo gel without the antibiotic. It aims to see if applying Vancogel(TM) can speed up healing and eliminate MRSA from wounds over one week compared to the placebo.See study design

What are the potential side effects?

Potential side effects may include skin irritation at the application site, allergic reactions in those sensitive to Vancomycin or other components of the gel formulation, and possibly systemic effects if absorption occurs.

Vancogel(R) Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have ulcers anywhere on my body.

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I have both new and old wounds.

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I have an open wound infected with MRSA.

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I have only one ulcer and it's smaller than 50 square centimeters.

Vancogel(R) Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one week

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one week

This trial's timeline: 3 weeks for screening, Varies for treatment, and one week for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Eliminate MRSA infection

Secondary outcome measures

More rapid healing of cSSTI

Vancogel(R) Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Drug Vancogel,Treatment,Kill MRSA,HealExperimental Treatment1 Intervention

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 II: PlaceboPlacebo Group1 Intervention

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Robert S Berman MDLead Sponsor

Robert S Berman, MDPrincipal Investigator - undefined

Jupiter Medical Center

University Of Kansas School Of Medicine (Medical School)

Vet Affairs Medical Ctr-W La (Residency)

Media Library

Vancomycin (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT00945152 — Phase 2

Bacterial Infection Research Study Groups: Placebo, Drug Vancogel,Treatment,Kill MRSA,Heal

Bacterial Infection Clinical Trial 2023: Vancomycin Highlights & Side Effects. Trial Name: NCT00945152 — Phase 2

Vancomycin (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00945152 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what maladies has Vancogel(R), a complex gel formulation of Vancomycin 1.25-1.50%, been prescribed?

"Staphylococcal infections, staphylococci-induced infection, and enterocolitis caused by Staphylococcus aureus can be effectively managed using Vancogel(R), a complex gel formulation containing Vancomycin 1.25-1.50%."

Answered by AI

Is participant recruitment currently underway for this trial?

"According to clinicaltrials.gov, this medical research is currently open for enrollment. It was first published on July 15th 2011 and has been revised as recently as July 19th 2022."

Answered by AI

How extensive is the sample size of this research endeavor?

"Affirmative. The information found on clinicaltrials.gov affirms that this medical investigation, which was first posted in July 15th 2011, is actively recruiting participants. Approximately 100 patients need to be recruited from 1 research centre."

Answered by AI

Are there other recorded experiments that have employed the complex Vancomycin 1.25-1.50% gel known as Vancogel(R)?

"Presently, there are 55 studies researching Vancomycin 1.25-1.50% in a complex gel formulation branded as Vancogel(R). 6 of these investigations have progressed to the late stage 3 clinical trial phase. While many trials for this therapy predominantly take place at Jupiter, Florida locations, researchers can be found in 315 other sites across America."

Answered by AI

Has the Vancomycin 1.25-1.50% complex gel formulation trademarked Vancogel(R) earned Food and Drug Administration approval?

"There is existing safety data, but no clinical evidence yet of efficacy, so our Power team assigned Vancogel(R)'s Vancomycin 1.25-1.50% a score of 2 on the scale from one to three."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Robert S Berman MD 2011. "Effects of MRSA Bactericidal Gel To Promote Healing and Eliminate MRSA in cSSTI Vancogel(TM)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00945152.

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