Non-Comparative Study of Open Abdomen That Require the Use of Negative Pressure Wound Therapy (NPWT) for Temporary Abdominal Closure
2018年2月6日 更新者:Smith & Nephew, Inc.
A Prospective, Non-Comparative, Open, Multi-Center Study to Assess the Use of a New Negative Pressure Wound Therapy (NPWT) System (RENASYS Touch and RENASYS AB) in Temporary Abdominal Closure (TAC) For the Management of the Open Abdomen
A study in which subjects with a Grade 1 or Grade 2 open abdomen that require the use of NPWT for temporary abdominal closure.
Subjects will use the NPWT system for up to 14 days, with a 21 day post study initiation follow-up assessment for latent complications and mortality.
研究概览
地位
撤销
研究类型
介入性
阶段
- 不适用
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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Illinois
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Chicago、Illinois、美国、60612
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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
描述
INCLUSION CRITERIA
- Eligible subjects must be properly consented before enrollment. If the subject is incapable of providing consent, emergency consent procedures will be followed, or the subject's legal representative must be asked to provide consent on the subject's behalf, per the IRB guidelines.
- Subjects must be at least eighteen (18) yeaTS of age, or older.
- Males and non-pregnant females.
- Grade 1 or Grade 2 open abdomen patients who would benefit from temporary abdominal closure (TAC) with topical Negative Pressure Wound Therapy (NPWT).
EXCLUSION CRITERIA
- Grade 3 and Grade 4 open abdomens.
- Malignancy in the reference wound bed or margins of the wound.
- Patients with non-enteric unexplored fistulas.
- High risk for imminent death, as determined by the attending surgeon and Principal Investigator (PI).
- Pre-existing large ventral hernia.
- Significant loss of abdominal wall fascia as a result of trauma or infection.
- Patients with a known hist01y of poor compliance with medical treatment.
- Patients who have participated in this trial previously and who were withdrawn.
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
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:RENASYS TOUCH NPWT System
Negative Pressure Wound Therapy (NPWT)
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NPWT applied to Grade 1 or Grade 2 open abdomen wounds for temporary abdominal closure for up to 14 days, with a 21 day post study initiation follow-up assessment.
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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 |
---|---|---|
To determine the number of days taken to achieve delayed primary fascial closure.
大体时间:14 days
|
NPWT applied to Grade 1 or Grade 2 open abdomen wounds for temporary abdominal closure for up to 14 days, with a 21 day post study initiation follow-up assessment.
|
14 days
|
次要结果测量
结果测量 |
大体时间 |
---|---|
To confirm the performance of the NPWT system in terms of maintenance of abdominal tissue domain
大体时间:14 days
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14 days
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To confirm the performance of the NPWT system in terms of: management of peritoneal fluid
大体时间:14 days
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14 days
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To confirm the performance of the NPWT system in terms of reduction in edema
大体时间:14 days
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14 days
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To confirm the performance of the NPWT system in terms of prevention of fixity
大体时间:14 days
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14 days
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To confirm the performance of the NPWT system in terms of prevention of infection
大体时间:14 days
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14 days
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To assess the ability of the NPWT system to prevent further deterioration of the open abdomen as classified by Bjorck et al., (2009)
大体时间:14 days
|
14 days
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To determine the type (method) of final closure of the open abdomen
大体时间:14 days
|
14 days
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To assess the number of days to achieve final closure of the open abdomen
大体时间:14 days
|
14 days
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To monitor the length of stay (days) in ICU and length of stay in hospital
大体时间:14 days
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14 days
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To monitor the number and type of re-operations throughout the course of the study
大体时间:14 days
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14 days
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To assess the number of dressing changes
大体时间:14 days
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14 days
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To record clinicians' overall opinion on the usability of the new device throughout the study
大体时间:14 days
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14 days
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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
- 学习椅:Jaime E Dickerson, PhD、Smith & Nephew, Inc.
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)
2016年12月1日
初级完成 (预期的)
2017年11月1日
研究完成 (预期的)
2017年12月1日
研究注册日期
首次提交
2016年11月17日
首先提交符合 QC 标准的
2018年2月6日
首次发布 (实际的)
2018年2月13日
研究记录更新
最后更新发布 (实际的)
2018年2月13日
上次提交的符合 QC 标准的更新
2018年2月6日
最后验证
2018年2月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 305-001-001-01
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.
Abdomenal Wound Trauma的临床试验
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Riverside University Health System Medical Center未知