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

Primary Purpose

Bacterial Infections, Wounds

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vancomycin 1.25-1.50% in a complex gel formulation trademarked Vancogel(R)
Placebo, complex gel formulation without Vancomycin
Sponsored by
Robert S Berman MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Infections focused on measuring Elimination of MRSA in open wounds, MRSA infected open wounds

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Robert S Berman MD /661 Maplewood Drive #21Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Drug Vancogel,Treatment,Kill MRSA,Heal

Placebo

Arm Description

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

Outcomes

Primary Outcome Measures

Eliminate MRSA infection
Cultures taken during and prior to treatment and after.

Secondary Outcome Measures

More rapid healing of cSSTI
The effects of the MRSA bactericidal gel will accelerate wound healing by eliminating the infection in cSSTI wounds

Full Information

First Posted
July 22, 2009
Last Updated
July 19, 2022
Sponsor
Robert S Berman MD
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1. Study Identification

Unique Protocol Identification Number
NCT00945152
Brief Title
Effects of MRSA Bactericidal Gel To Promote Healing and Eliminate MRSA in cSSTI Vancogel(TM)
Acronym
Vancogel(R)
Official Title
Topical MRSA Bactericidal Gel to Eliminate MRSA and Promote Accelerated Healing of cSSTI of Open Wounds
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2011 (Actual)
Primary Completion Date
December 15, 2024 (Anticipated)
Study Completion Date
December 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Robert S Berman MD

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infections, Wounds
Keywords
Elimination of MRSA in open wounds, MRSA infected open wounds

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Drug Vancogel,Treatment,Kill MRSA,Heal
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Vancomycin 1.25-1.50% in a complex gel formulation trademarked Vancogel(R)
Other Intervention Name(s)
Vancogel (R)# 77708836/Trademark issued 12-11-2012 Patent issued 02-02-2016 # 9248159, Topical MRSA Bactericidal Gel, Vancomycin complex gel formulation
Intervention Description
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
Intervention Name(s)
Placebo, complex gel formulation without Vancomycin
Other Intervention Name(s)
Safgel
Intervention Description
Complex gel formulation applied as the placebo and is unknown because of the trial design. Complex gel formulation without Vancomycin
Primary Outcome Measure Information:
Title
Eliminate MRSA infection
Description
Cultures taken during and prior to treatment and after.
Time Frame
One week
Secondary Outcome Measure Information:
Title
More rapid healing of cSSTI
Description
The effects of the MRSA bactericidal gel will accelerate wound healing by eliminating the infection in cSSTI wounds
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert S Berman, MD
Phone
561-628-0040
Email
bermanmd@comcast.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert S Berman, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Robert S Berman MD /661 Maplewood Drive #21
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert S Berman, MD
Phone
561-628-0040
Email
bermanmd@comcast.net
First Name & Middle Initial & Last Name & Degree
Robert S Berman, MD

12. IPD Sharing Statement

Learn more about this trial

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

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