Electroceutical Dressing Technology Against Wound Microbial Biofilm Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 6
- 主要终点
- Response to the use of EDT treatment in prevention of wound biofilm infection
研究概览
简要总结
There are currently limited treatments available that show anti-biofilm efficacy for wound infection management Biofilms account for over 80% of infections and approximately 65% of nosocomial infections caused by microorganisms in the developed world involve biofilms. There clearly is a need for cost effective, highly stable, easily obtained biofilm targeted strategies for treatment of chronic wound biofilm infections.
The information generated from this project has the potential of providing considerable benefits to wound care by determining the efficacy of EDT dressing in managing wound biofilm infection and efficacy in wound healing and closure. Such knowledge could help therapeutic strategies and could provide information for future clinical studies to further understanding -of EDT wound dressings.
详细描述
This is a randomized open-label clinical study to test the efficacy of the treatment protocol using an optimized EDThi & EDTlo sequential approach in infected or high risk of infection burn/trauma/surgery chronic wounds against biofilm infection. This trial will determine the efficacy of EDT dressing against wound biofilm infection. subjects will be randomized to one of the two groups: 1) standard of care (SoC) only and 2) SoC + EDT dressing treatment. In group 2, in addition to SoC, the patients will apply the EDThi dressing (PED-10) on the wound(s) for the first 3 weeks following enrollment followed by Procellera® for additional 3 weeks. The use of dressings will be discontinued anytime if complete wound closure is achieved.
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
- Single (Outcomes Assessor)
盲法说明
to avoid bias, the personnel performing the biofilm analysis (Primary outcome) will be blinded towards the study groups.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18 years and older
- •subjects willing and able to provide informed consent
- •patients with infected chronic trauma or surgical wounds
- •wound(s) must be able to be covered by the EDT dressing
- •All patients, with wounds below the knee, must have wound tissue oxygenation adequate to support wound healing per provider discretion, this may be defined by one or more of the following perfusion values within 6 months on enrollment: peri-wound transcutaneous oxygen measurements ≥ 25 mmHg (TCOM),Ankle Brachial Index (ABI) >0.7, or a Toe pressure (TP) > 40 mmHg, If none of these tests were performed during standard of care, then a trained study team member may obtain a TCOM measurement after the patient has consented and before they are enrolled. If there are multiple perfusion values that conflict, then a physician will review and determine if they are eligible for enrollment. If a patient has had a recent re-vascularization, the patient may be enrolled once adequate perfusion has been verified.
- •Subjects must be able to read and understand English.
排除标准
- •Individuals who are deemed unable to understand the procedures, risks and benefits of the study, ie. Informed consent will be excluded
- •Pregnant women
- •Wound tissue not available for analysis
- •Patient with known sensitivity or allergic reaction to zinc or silver
- •Current active diagnosis of Osteomyelitis at the target wound site, that is untreated, based on clinical diagnosis per EMR.
结局指标
主要结局
Response to the use of EDT treatment in prevention of wound biofilm infection
时间窗: 6 weeks
Impact of EDT treatment in prevention of incidence of wound biofilm infection
次要结局
- wound microbiome in SoC and SoC+ EDT treatment.(3 weeks)
- rate of wound closure 6 weeks post-treatment as compared to baseline(6 weeks)
- Percent of patients with response to EDT treatment on week 6 as compared to SoC only group(6 weeks)
研究者
Dr. Sashwati Roy
Professor of Surgery
Indiana University