Prospective Evaluation of MicroMatrix® Flex in Wounds Complicated by Tunneling and Undermining
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 3
- 主要终点
- Relative rate of closure of a tunneling or undermining feature
研究概览
简要总结
To evaluate the safety and performance of MicroMatrix® Flex in subjects with wounds complicated by tunneling and/or undermining features.
详细描述
The purpose of this study is to evaluate the safety and performance of MicroMatrix® Flex in subjects with wounds complicated by tunneling and/or undermining features. Prospective data will be collected to assess the rate of wound area/volume reduction (progression toward closure) and post-operative complications at 12 weeks, and rate of skin graft take, when applicable, up to 16 weeks follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is ≥ 22 years at the time of consent
- •Patient with a diagnosis of pressure injury, venous ulcer, diabetic ulcer, necrotizing soft tissue infection associated wound, dehiscing and/or draining wounds associated with open abdominal procedures, or any indication per the Instructions For Use
- •Patient is willing and able to adhere to protocol requirements and comply with the study follow-up regimen
- •Patient has reviewed the IRB/IEC-approved consent form, has been properly consented per the protocol and has documented their consent to participate in the study by signing the IRB/IEC-approved consent form
排除标准
- •Burn as etiology of wound
- •Unmanaged infection and/or osteomyelitis as determined pre-operatively
- •Known allergy, hypersensitivity, or objection to porcine materials, due to religion, culture, or other
- •Patient report of concurrent participation in another clinical trial that would interfere with this study
- •Any condition, concomitant medication, or concomitant treatment that, in the opinion of the investigator, would preclude the use of the study device or preclude the patient from completing the follow-up requirements
研究组 & 干预措施
Subjects with tunneling and/or undermining wounds
MicroMatrix Flex, MicroMatrix UBM Particulate, and Cytal Wound Matrix 2-Layer will be used to treat the wound.
干预措施: MicroMatrix® Flex (Device)
Subjects with tunneling and/or undermining wounds
MicroMatrix Flex, MicroMatrix UBM Particulate, and Cytal Wound Matrix 2-Layer will be used to treat the wound.
干预措施: MicroMatrix® UBM Particulate (Device)
Subjects with tunneling and/or undermining wounds
MicroMatrix Flex, MicroMatrix UBM Particulate, and Cytal Wound Matrix 2-Layer will be used to treat the wound.
干预措施: Cytal® Wound Matrix 2-Layer (Device)
结局指标
主要结局
Relative rate of closure of a tunneling or undermining feature
时间窗: At 12 weeks or skin graft visit
Relative rate of closure of a tunneling or undermining feature as determined manually, through measurement of opening size and depth of managed wound at 12 weeks or skin graft visit, relative to first visit/application post debridement
次要结局
- Relative rate of closure of a tunneling or undermining feature(First device application through to 12 weeks)
- Number of wound infections, seromas, and hematomas(First device application through to 12 weeks)
- Number of managed wounds which require removal of devices(First device application through to 12 weeks)
- Length of stay in-patient(First device application through to 12 weeks)
- Relative rate of overall wound closure(First device application through to 12 weeks)