Topical MRSA Bactericidal Gel to Eliminate MRSA and Promote Accelerated Healing of cSSTI of Open Wounds
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Eliminate MRSA infection
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Drug Vancogel,Treatment,Kill MRSA,Heal
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.
干预措施: Vancomycin 1.25-1.50% in a complex gel formulation trademarked Vancogel(R) (Drug)
Placebo
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
干预措施: Placebo, complex gel formulation without Vancomycin (Drug)
结局指标
主要结局
Eliminate MRSA infection
时间窗: One week
Cultures taken during and prior to treatment and after.
次要结局
- More rapid healing of cSSTI(3 weeks)
研究者
Robert S Berman MD
Sponsor-Investigator
Robert S Berman MD