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

NCT00945152 | Unknown Phase 2

• 2 other identifiers: WIRB study # 1111446None yet, self funding
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Elimination of MRSA in open wounds; MRSA infected open wounds

Outcome Measures

Primary Outcomes (1)

• Eliminate MRSA infection

  Cultures taken during and prior to treatment and after.

  One week

Secondary Outcomes (1)

• More rapid healing of cSSTI

  3 weeks

Study Arms (2)

Drug Vancogel,Treatment,Kill MRSA,Heal

EXPERIMENTAL

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.

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo, complex gel formulation without Vancomycin

Interventions

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

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.

Also known as: Vancogel (R)# 77708836/Trademark issued 12-11-2012 Patent issued 02-02-2016 # 9248159, Topical MRSA Bactericidal Gel, Vancomycin complex gel formulation

Drug Vancogel,Treatment,Kill MRSA,Heal

Placebo, complex gel formulation without Vancomycin DRUG

Complex gel formulation applied as the placebo and is unknown because of the trial design. Complex gel formulation without Vancomycin

Also known as: Safgel

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Robert S Berman MD: lead

Study Sites (1)

Robert S Berman MD /661 Maplewood Drive #21

Jupiter, Florida, 33458, United States

RECRUITING

MeSH Terms

Conditions

Bacterial Infections; Wounds and Injuries

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Robert S Berman, MD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert S Berman, MD

CONTACT

561-628-0040; bermanmd@comcast.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: July 22, 2009
• First Posted: July 23, 2009
• Study Start: July 15, 2011
• Primary Completion: December 15, 2024
• Study Completion: December 15, 2024
• Last Updated: July 21, 2022

Record last verified: 2022-07

Locations

US (1)