NCT02007824已完成不适用
Clinical Trial to Evaluate Efficacy and Safety of Ultrasonic Surgical Device (ULSC-12D)in Chronic Pressure Ulcer
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- The number of microorganisms on wound bed
研究概览
简要总结
Study objective The purpose of this trial is to evaluate the efficacy and safety of the investigational device, ULSD-12D, as Compared to the comparator, SONOCA-180, in chronic wound.
详细描述
- Study design Multi-center, randomized clinical trial
- Study population Adults with chronic wound
- Investigational device treatment procedure Before Treatment: The subject's eligibility (inclusion/exclusion criteria) will be assessed,and apply the Study Device or Comparator on their wound in a randomized manner. Post-Treatment: All subjects will take pictures of the wound area and measured the number of microorganism and wound size.
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 (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •over 20 years of age
- •subject who has untreated wounds
- •subject who has wound size over 3cm x 3cm
- •subject who has wound over stage 2
排除标准
- •cellulitis
研究组 & 干预措施
ULSD-12D
Experimental
ultrasound surgical device made by Ultech.
干预措施: ULSD-12D (Device)
SONOCA-180
Active Comparator
ultrasound surgical device made by Soering
干预措施: SONOCA-180 (Device)
结局指标
主要结局
The number of microorganisms on wound bed
时间窗: Baseline and 30minuts post debridement
Investigator measured the number of microorganisms on wound bed at pre and post debridement using nitrocellulose filter.
次要结局
- necrotic tissue region(Baseline and 30minuts post debridement)
研究者
Chan-Yeong Heo
Assistant professor
Seoul National University Hospital
研究点 (6)
Loading locations...
相似试验
已完成
不适用
Assessment of an Investigational Frequent Replacement Silicone Hydrogel LensRefractive AmetropiaNCT04085328Alcon Research675
招募中
2 期
The Safety and Efficacy of Fecal Microbiota Transplantation in a Population With Major Depressive DisorderTreatment Resistant DepressionDepressionNCT04805879University of Calgary80
已完成
不适用
Safety and Effectiveness of an Auricular SprayExcessive Ear WaxNCT06085443YSLab99
Unknown
不适用
Safety and Efficacy of Targeted IL-13 Rα2 or B7-H3 UCAR-T for Advanced GliomaAdvanced GliomaComplication of Chimeric Antigen Receptor (CAR-T) Cell TherapyNCT05752877Second Affiliated Hospital of Soochow University12
尚未招募
2 期
Treatment of Epidermoid CystsEpidermoid CystNCT05597995Goldman, Butterwick, Fitzpatrick and Groff10