Bacterial InfectionsPhase 2Vancogel(R)NCT00945152
Effects of MRSA Bactericidal Gel To Promote Healing and Eliminate MRSA in cSSTI Vancogel(TM)
A Phase 2 study testing Vancomycin 1.25-1.50% in a complex gel formulation trademarked Vancogel(R) in people with Bacterial Infections and Wounds, run by Robert S Berman MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bacterial Infections, Wounds
- What is being tested?
- Vancomycin 1.25-1.50% in a complex gel formulation trademarked Vancogel(R)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2011to 15 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Robert S Berman MD /661 Maplewood Drive #21
Jupiter, Florida, 33458
Robert S Berman, MD, 561-628-0040, bermanmd@comcast.net
Robert S Berman, MD
About this study
Official title: Topical MRSA Bactericidal Gel to Eliminate MRSA and Promote Accelerated Healing of cSSTI of Open Wounds
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.
Read the 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.
- Conditions
- Bacterial Infections, Wounds
- Being tested
- Vancomycin 1.25-1.50% in a complex gel formulation trademarked Vancogel(R), Placebo, complex gel formulation without Vancomycin
- Keywords
- Elimination of MRSA in open wounds, MRSA infected open wounds
- Medical subject headings
- Bacterial Infections, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vancomycin 1.25-1.50% in a complex gel formulation trademarked Vancogel(R)Drug
Also called Vancogel (R)# 77708836/Trademark issued 12-11-2012 Patent issued 02-02-2016 # 9248159, Topical MRSA Bactericidal Gel, Vancomycin complex gel formulation
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.
Placebo, complex gel formulation without VancomycinDrug
Also called Safgel
Complex gel formulation applied as the placebo and is unknown because of the trial design. Complex gel formulation without Vancomycin
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: Placebo, complex gel formulation without Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eliminate MRSA infection
Cultures taken during and prior to treatment and after.
Measured: One week
Secondary outcomes (1)
More rapid healing of cSSTI
The effects of the MRSA bactericidal gel will accelerate wound healing by eliminating the infection in cSSTI wounds
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2009 (estimated)
- Study start15 Jul 2011
- Primary completion15 Dec 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert S Berman MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Robert S Berman MD, Robert S Berman MD
- Investigators
- Robert S Berman, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00945152
- Sponsor's protocol ID
- WIRB study # 1111446
- Other IDs
- None yet, self funding
- Acronym
- Vancogel(R)
- Status last verified
- Jul 2022
- First submitted
- 22 Jul 2009
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical MRSA Bactericidal Gel to Eliminate MRSA and Promote Accelerated Healing of cSSTI of Open Wounds
- ClinicalTrials.gov ID
- NCT00945152
- Acronym / sponsor ID
- Vancogel(R) / WIRB study # 1111446
- Conditions
- Bacterial Infections, Wounds
- Keywords
- Elimination of MRSA in open wounds, MRSA infected open wounds
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Robert S Berman MDUniversity, hospital or other
- Study start
- 15 Jul 2011 (actual)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 23 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug Vancogel,Treatment,Kill MRSA,Heal | Experimental | Drug: Vancomycin 1.25-1.50% in a complex gel formulation trademarked Vancogel(R)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. |
| Placebo | Placebo comparator | Drug: Placebo, complex gel formulation without VancomycinHalf 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vancomycin 1.25-1.50% in a complex gel formulation trademarked Vancogel(R)Also: Vancogel (R)# 77708836/Trademark issued 12-11-2012 Patent issued 02-02-2016 # 9248159, Topical MRSA Bactericidal Gel, Vancomycin complex gel formulationTopical 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. | Drug | Drug Vancogel,Treatment,Kill MRSA,Heal |
| Placebo, complex gel formulation without VancomycinAlso: SafgelComplex gel formulation applied as the placebo and is unknown because of the trial design. Complex gel formulation without Vancomycin | Drug | Placebo |
Primary outcome
Eliminate MRSA infection
Time frame: One week
Cultures taken during and prior to treatment and after.
1 secondary outcome
More rapid healing of cSSTI
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert S Berman, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vancomycin 1.25-1.50% in a complex gel formulation trademarked Vancogel(R) in people with Bacterial Infections and Wounds, run by Robert S Berman MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert S Berman, MD (561-628-0040, bermanmd@comcast.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eliminate MRSA infection (time frame: One week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.