Patterned Electric Dressing Effects on Open Wounds (PED)
2022年4月12日 更新者：Gayle Gordillo
- This study is a pilot feasibility study to determine treatment effects to estimate sample size for future studies that evaluate wound bacteria colonization.
- The secondary objective of this study aims to observe the effect of PED on an open wound and its effects in wound bacteria colonization.
研究概览
详细说明
This study is designed as a pilot study where 30 patients receiving a below the knee amputation with at least one open wound on the limb will be enrolled.
Patients are identified through medical records.
The patients will be selected based on inclusion and exclusion criteria through pre-screening through the Comprehensive Wound Center's Limb Preservation Program and wound physicians/providers at Indiana University.
The decision of amputation is made independently of the study and is solely made by the patient and their physician/provider.
The provider decides based on the severity of the limb's condition if/when the limb should be amputated and will schedule this surgery with the patient based on current clinical standard of care.
Study participation is decided independent of clinical decision.
Patients enrolled in the study will wear the Patterned Electric Dressing (PED) on the wound(s) for up to 3 weeks or until amputation, whichever comes first and will have up to a total of 4 study visits.
研究类型
观察性的
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Indiana
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Indianapolis、Indiana、美国、46202
- IU Health Methodist Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
In this study 30 patients receiving a below the knee amputation with at least one open wound on the limb will be enrolled.
Patients are identified through medical records.
The patients will be selected based on inclusion and exclusion criteria through pre-screening through the Comprehensive Wound Center's Limb Preservation Program and wound physicians/providers at Indiana University.
Patients enrolled in the study will wear the Patterned Electric Dressing (PED) on the wound(s) for up to 3 weeks or until amputation, whichever comes first and will have up to a total of 4 study visits.
描述
Inclusion Criteria:
- Ages 18 years and older
- Patients identified to be receiving a non-traumatic below the knee amputation within 3 weeks of enrollment
The affected limb to be amputated must have at least one open wound
- Wound(s) must be able to be covered by 3x3 dressing
- Subjects willing and able to provide informed consent
Exclusion Criteria:
- Pregnant women
- Prisoners
- Individuals lacking consent capacity
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Bacterial colonization & culture
大体时间：3 weeks or until amputation, whichever comes first
|
Bacteria colonization (cultures results high, moderate, low or negative).
|
3 weeks or until amputation, whichever comes first
|
|
Necrotic tissue assessed through light microscopy of tissue biopsies
大体时间：3 weeks or until amputation, whichever comes first
|
Hematoxylin and Eosin staining of tissue sections to measure extent of tissue necrosis at baseline and compared to tissue obtained at surgery after PED treatment.%
necrotic tissue will be measured.
|
3 weeks or until amputation, whichever comes first
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Wound area measured before and after wound treatment
大体时间：3 weeks or until amputation, whichever comes first
|
To determine the effect of PED on % wound closure based on wound measurements at baseline and end of PED treatment.
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3 weeks or until amputation, whichever comes first
|
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Bacterial biofilm through Scanning Electron Microscopy analysis
大体时间：3 weeks or until amputation, whichever comes first
|
Perform scanning electron microscopy to detect bacterial biofilm (high, moderate, low or negative) before and after PED treatment.
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3 weeks or until amputation, whichever comes first
|
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Bacterial contamination assessed through Colony Forming Units
大体时间：3 weeks or until amputation, whichever comes first
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Colony forming units will be measured from tissue samples and dressings to quantitate bacterial contamination levels at baseline and after PED treatment.
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3 weeks or until amputation, whichever comes first
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Gordillo Gayle, MD、Indiana University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Costerton JW, Stewart PS, Greenberg EP. Bacterial biofilms: a common cause of persistent infections. Science. 1999 May 21;284(5418):1318-22. doi: 10.1126/science.284.5418.1318.
- Ammons MC, Ward LS, James GA. Anti-biofilm efficacy of a lactoferrin/xylitol wound hydrogel used in combination with silver wound dressings. Int Wound J. 2011 Jun;8(3):268-73. doi: 10.1111/j.1742-481X.2011.00781.x. Epub 2011 Apr 1.
- Douglas LJ. Medical importance of biofilms in Candida infections. Rev Iberoam Micol. 2002 Sep;19(3):139-43.
- Schachter B. Slimy business--the biotechnology of biofilms. Nat Biotechnol. 2003 Apr;21(4):361-5. doi: 10.1038/nbt0403-361. No abstract available.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2022年4月1日
初级完成 (预期的)
2023年4月1日
研究完成 (预期的)
2023年11月1日
研究注册日期
首次提交
2019年3月11日
首先提交符合 QC 标准的
2019年7月11日
首次发布 (实际的)
2019年7月12日
研究记录更新
最后更新发布 (实际的)
2022年4月19日
上次提交的符合 QC 标准的更新
2022年4月12日
最后验证
2022年4月1日
更多信息
与本研究相关的术语
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.