A Multicentre Prospective Study Evaluating an Off-loading Mattress Overlay System in Healing of Stage 3 Pressure Ulcers (DABIRPrU)
2022年11月3日 更新者：SerenaGroup, Inc.
A Multicentre Prospective Study Evaluating an Off-loading Mattress Overlay System in Healing of Stage 3 Pressure Ulcers (DABIRPrU)
This study will evaluate the use of a mattress overlay system to promote the healing of full thickness pressure ulcers.
The overlay is placed over the patient's bed making it easier for patients to get in and out of bed.
In addition, the overlay has blue tooth capabilities that will allow clinicians to remotely monitor adherence with the device.
研究概览
详细说明
The study is a multi-center, prospective, study designed to evaluate the use of an alternating mattress overlay in the treatment of stage 3 pressure ulcers.
After screening, eligible subjects will receive a mattress overlay system for the 4 weeks of treatment.
The mattress is fitted to the patient's bed/mattress in his/her home or skilled nursing facility (SNF).
Patients responding to the offloading regimen (percent wound area reduction >20% at 4 weeks) may use the overlay for up to 12 additional weeks.
The SOC in this study is debridement, proper moisture balance, reduction of bacterial burden and nutritional counseling.
研究类型
介入性
注册 (预期的)
30
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。
学习联系方式
- 姓名：Kristy Breisinger
- 电话号码：412-212-0123
- 邮箱：kbreisinger@serenagroups.com
学习地点
-
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Pennsylvania
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Butler、Pennsylvania、美国、16001
- 招聘中
- Sunnyview
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接触：
- Laura Serena
- 邮箱：lserena@serenagroups.com
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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
- Subjects are male or female, 18 years of age or older.
- Pressure ulcer/injury present for greater than 4 weeks (documented in the medical record).
- Subject has clinical documentation of no visible wound improvement in the post four weeks of standard of care. Objectively, less than 20% healing in the past four weeks from the first treatment visit.
- Study ulcer is a minimum of 2.0 cm2 and a maximum of 50 cm2 at first treatment visit.
- The subject is able and willing to follow the protocol requirements.
- Subject has signed informed consent.
Exclusion Criteria
- Subject has major uncontrolled medical disorder such as serious cardiovascular, renal, liver or pulmonary disease, lupus, palliative care or sickle cell anemia.
- Subject currently being treated for an active malignant disease or subjects with history of malignancy within the wound.
- The Subject has other concurrent conditions that, in the opinion of the Investigator, may compromise subject safety.
- Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study.
- Subject is pregnant or breast feeding.
- Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids >10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within one month prior to first Screening Visit, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
- Index ulcer has been previously treated with tissue engineered materials (e.g. Apligraf® or Dermagraft®) or other scaffold materials (e.g. Oasis, Matristem) within the l 30 days preceding the first treatment visit.
- Affected extremity requiring hyperbaric oxygen during the trial or within 2 weeks of treatment visit 1.
- Known HbA1C >12%.
- Mini-nutritional assessment Malnutrition Indication score <17.
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：Dabir Surface Mattress Overlay System
Eligible patients are treated with a mattress overlay system and standard of care (debridement, proper moisture balance, reduction of bacterial burden and nutritional counseling).
Subjects will be seen weekly for 4 weeks.
Patients who respond to the offloading device, may use the overlay for an additional 12 weeks with monthly follow-up visits in the clinic or their home.
Subjects undergo study procedures on a weekly basis.
|
Dabir Surface mattress overlay system consists of a controller and a low-profile alternating pressure (AP) surface (placed over a non-powered mattress) with hundreds of air-filled geometric nodes arranged in rows. .
The multiple rows of nodes inflate and deflate in alternating sequence every five minutes.
During deflation phase, the skin and soft tissues experience reduced pressure/loading and enhanced perfusion.
In conjunction with Standard of Care: Debridement, Proper moisture balance, off-loading, reduce bacterial burden and nutritional counseling.
其他名称：
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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 |
|---|---|---|
|
Wound Reduction in Surface Area
大体时间：4 week
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The percentage change in ulcer size (wound area reduction) from baseline to 4 week completion
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4 week
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pain assessment
大体时间：4 weeks
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Assessment of the pain level linked to the wound, using a numeric pain scale.
Numeric Pain Scale from 0-10 anchored by word descriptors at each end.
A numerical scale will be used to assess pain.
Subject will be asked to indicate a numerical value that best represents the pain intensity at ulcer site on a scale of 0 to 10 anchored by "word descriptors" at each end, as "no pain" on the left side and "worst possible pain" on the right side of the number line.
The number 0 represents "no pain", the number 5 represents "moderate pain" and the number 10 represents the "worst possible pain".
The subject indicates the level of pain intensity by selecting a number on the line that represents their perception of their current state.
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4 weeks
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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。
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 (实际的)
2021年10月4日
初级完成 (预期的)
2023年5月1日
研究完成 (预期的)
2023年6月30日
研究注册日期
首次提交
2021年8月13日
首先提交符合 QC 标准的
2021年8月27日
首次发布 (实际的)
2021年9月2日
研究记录更新
最后更新发布 (实际的)
2022年11月4日
上次提交的符合 QC 标准的更新
2022年11月3日
最后验证
2022年11月1日
更多信息
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.