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

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Bacterial Infections, Wounds

In brief

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.

Key facts

Study ID

NCT00945152

Run by

Robert S Berman MD

People needed

100

Starts

2011-07-15

Expected to finish

2024-12-15

Last updated by the study team

2022-07-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Robert S Berman MD /661 Maplewood Drive #21 — Jupiter, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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