NCT00764296已完成不适用
Collection of Samples for the Evaluation of Wound Biofilm in Acute and Chronic Wounds
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- The Specific Aim of examining wounds microscopically is to attempt to demonstrate the presence of biofilm in chronic wounds and to understand these populations on a cellular level.
研究概览
简要总结
The Specific Aim of examining wounds microscopically is to attempt to demonstrate the presence of biofilm in chronic wounds and to understand these populations on a cellular level.
详细描述
Characterizing the surface of the acute wound is important because the characterization can act as a control and can give a standard by which to judge the microscopic pathology observed in chronic wounds.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •The subject must be 18 years of age or older.
- •The subject must have a full thickness acute or chronic wound. The sampling is restricted to subjects with the presence of a full thickness wound in order to reduce any risk for infection to the subject. Biopsying a wound that is already full thickness should not increase the subject's risk.
- •The subject must have no history of coagulopathy
- •If the subject's acute wound will be biopsied, the wound must be less than 48 hours old.
- •The subject must be a candidate for sharp debridement
排除标准
- •The subject may not have myelosuppression indicated by a CBC which may include a WBC less than 1500 cells per cubic millimeter, platelet count less than 125,000 per cubic millimeter, or hemoglobin less than 9 g/dL.
- •The subject may not be on anticoagulation therapy because anticoagulation therapy increases the risk of bleeding.
- •The subject may not have a TCpO2 less than 20 torr. Subjects with low tissue oxygenations may have some risk from biopsy due to their poor ability to heal and, therefore, are excluded.
- •The subject may not be pregnant
- •The subject's wound must not be in the region of the face, neck, or genitalia
结局指标
主要结局
The Specific Aim of examining wounds microscopically is to attempt to demonstrate the presence of biofilm in chronic wounds and to understand these populations on a cellular level.
时间窗: 2 years
次要结局
未报告次要终点
研究者
Randall Wolcott
Prinicipal Investigator
Southwest Regional Wound Care Center
研究点 (1)
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