The Relationship Between Bacterial Load and the Clinical Outcomes for Integra™ in Operative Wounds
试验速览
- 阶段
- 不适用
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Determine a threshold in which Integra is tolerant to bacteria that yields positive results (healing). The investigators believe that this device is more tolerant to bacterial load then current perception.
研究概览
简要总结
Proportion of postoperative complications (infections, dehiscence, graft slough) after initial application of Integra™
详细描述
This is a study examining the use of Integra™ for the treatment of lower extremity wounds to better understand the relationship between bacteria contamination levels and post-operative complications. Wounds requiring operative application of Integra™ alone or Integra™ followed by a planned subsequent application of a STSG will be enrolled into this study.
The tolerance of Integra™ to bacterial bioburden at the time of application will be determined by observing their respective postoperative wound complications and correlating these findings with quantitative bacterial counts, qualitative culture results, and bacterial and wound protease levels at the time of Integra™ alone application or Integra™ followed by STSG application.
Patients will then be followed until complete healing has occurred or until 16 weeks, whichever comes first.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female age 18-
- •Full-thickness wounds below the knee.
- •Patients who require, in the opinion of the Investigator, operative application of Integra™.
- •Patients able and willing to comply with the study protocol.
排除标准
- •Male or Female under 18 or over 90
- •Patients that do not have Full-thickness wounds below the knee
- •Patients who do not require, in the opinion of the Investigator, operative application of Integra™.
- •Patients that are not able or willing to comply with the study protocol.
结局指标
主要结局
Determine a threshold in which Integra is tolerant to bacteria that yields positive results (healing). The investigators believe that this device is more tolerant to bacterial load then current perception.
时间窗: 1 year
Quantitative CFUs will be obtained by obtaining tissue from the wound at the time of debridement from otherwise discarded tissue. After tissue cultures are obtained and sent to a designated microbial lab for analysis. Tissue culture is to be obtained from the central aspect of the wound bed. These cultures will be processed and analyzed for research purposes. Qualitative cultures will be obtained as per SOC and sent to the local lab per customary fashion. Qualitative bacterial protease and human inflammation protease indications will be obtained by sampling and testing two separate wound fluid swabs on investigational devices; WOUNDCHEKTM Bacterial Status and WOUNDCHEKTM Protease Status. Bacterial Status detects enzymes that are present when bacteria have become pathogenic while Protease Status detects enzymes present when the wound is in a chronically inflamed state. The tests will be obtained from Woundchek Labs.
次要结局
未报告次要终点
研究者
Christopher Attinger, M.D.
Professor and Director of the Center for Wound Healing
Georgetown University