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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

Must not have

Wounds greater than 50sq. cm

No wounds deeper than soft tissue

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 weeks

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a wound larger than 50 square centimeters.

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I do not have any deep wounds.

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I have a sore that developed after radiation treatment.

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I have more than one wound.

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I have stage 4 skin ulcers.

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I have a bleeding disorder.

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I have ulcers caused by my cancer.

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I have a history of heart disease, skin conditions, or immune system issues.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Eliminate MRSA infection

Secondary study objectives

More rapid healing of cSSTI

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 / 12Eligibility criteria met