NCT02274207Unknown4 期
Phase IV Study of Antibacterial Effect on Silver Dressing of NPWT
适应症
试验速览
- 阶段
- 4 期
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Days to patient discharge
研究概览
简要总结
The purpose of this study is to test therapeutic benefits of silver dressing compared with non-silver dressing in NPWT(Negative pressure wound therapy). Silver dressing may antibacterial effect on infected diabetes mellitus foot.
详细描述
Investigator will recruit sixty patients. Participant will be randomly assigned to one of two groups. One is using silver dressing group in NPWT, another is using non-silver dressing group in NPWT. Participant will visit in screening day, NPWT apply day and F/u day for 4 months. Investigators will conduct to check the wound base, Lab, wound culture.
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
- None
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
- •The patient above 20 years and has type I, II of diabetes mellitus foot ulcer
- •Infected ulcer has one of below.
- •clinically infection symptom in ulcer area : warmth, erythema, tenderness/swelling
- •induration, purulent discharge etc.
- •Confirmed case of bacteria in wound culture.
- •Conformed case of abnormal range of erythrocyte sedimentation rate (ESR)/C-reactive protein(CRP) level in lab.
- •Has to be applied NPWT because suture is impossible in ulcer area.
- •The patient voluntary agreed to this protocol.
- •In the opinion of investigator, It is suitable to participate in this study.
排除标准
- •Infection in bone so patient need amputation
- •Female with childbearing, lactating or not agree to prevent pregnancy.
- •Has Sepsis, Osteomyelitis
- •Has Connective tissue disease of disturbance of healing of wound Ex) Rheumarthritis,systemic lupus erythematosus(SEL), myalgia.
- •The patient to diagnosis of Sickle sell disease or Charcot's joint.
- •The patient stability treated chronic wasting disease.
- •Malignant tumor or history of malignant disease. (Not diagnosis of complete recovery.)
- •The patient treated chemotherapy, radiation therapy, immune-suppressants therapy,adrenocortical hormones therapy.
- •Although necrosis tissue is removed, the target ulcer did not heal because of gangrenous, necrosis tissue or purulent pyorrhea.
- •Has ulcer with cardiac arrhythmia thrombus, venous insufficiency, diabetic necrobiosis lipoidic.
- •In case of using prohibited concomitant medications during study.
- •a. Oral system steroid b. Immune-suppressive drug c. Unfractionated heparin infusion d. improper drugs in the opinion of investigator.
- •Hypersensitivity with applicators. (NPWT, Silver)
- •The patient participated in other clinical trials within 30 days
- •In the opinion of investigator, the patient is not suitable to participate in this study.
结局指标
主要结局
Days to patient discharge
时间窗: up to 4 weeks
-Examine the days from applied medical device to discharge.
次要结局
- Number of surgical debridement after NPWT(up to 8 weeks)
- Rate of adverse event(up to 4 months (if adverse event appeared, Investigator follow until the disappearance of the symptom)
- Complete infection clear rate in wound culture results(up to 4 months)
- Days to infection clearance in wound culture results(4 months (at least once a week for 4 weeks / After dischage, every participant visit day(for 3 months)))
- Wound closure rate(up to 4 months)
- Lab - deviation of level(up to 4 months)
- Days to complete wound closure(4 months (at least once a week for 4 weeks / After dischage, every participant visit day(for 3 months)))
- Days of NPWT application period(up to 8 weeks)
- Elevation of wound evaluations grade(4 months (at least once a week for 4 weeks / After dischage, every participant visit day(for 3 months)))
研究者
Woojin Choi
Orthopedics
Severance Hospital
研究点 (2)
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