Use of Cytal® Wound Matrix and MicroMatrix® for the Management of Wounds
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Number of Participants With Completely Healed Wounds
研究概览
简要总结
This is an observational study to assess the safety and efficacy of MicroMatrix® alone or in combination with Cytal® Wound Matrix on primary measures of wound healing.
详细描述
A single-site, prospective, observational clinical study of Cytal® Wound Matrix alone or in combination with MicroMatrix® for the management of wounds. Up to 100 patients with multiple wound types including but not limited to, venous ulcers, diabetic foot ulcers, trauma wounds, and external surgical wounds will be treated either with Cytal® Wound Matrix alone or with Cytal® Wound Matrix and MicroMatrix® for wounds exceeding 3mm in depth. Wound healing efficacy, effect of treatment on patient-reported quality of life, complete wound management, wound-related adverse event, and wound pathology will be measured. The protocol defined patient follow-up is 12 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has at least one wound that the treating physician determines may be treated with Cytal® with or without MicroMatrix®.
- •Subject is at least 21 years of age.
- •Subject is willing and able to adhere to protocol requirements and agrees to participate in the study program and comply with the study follow-up regimen.
- •Subject or legal representative is willing to provide informed consent.
- •For females of reproductive potential, confirmed negative urine pregnancy test at enrollment.
排除标准
- •Allergy or hypersensitivity to materials in porcine-based study products (per subject report) or personal preference.
- •Subject report of concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study.
- •The subject has any condition that, in the Investigator's opinion, would warrant exclusion from the study or prevent the subject from completing the study.
- •The subject's wound shows evidence of infection as determined by the Principal Investigator (which may be indicated by the presence of: elevated WBC, pus, moderate or greater discharge, abnormal odor, or acute osteomyelitis).
- •Wound with exposed organs or hardware.
- •Wound with burn etiology.
结局指标
主要结局
Number of Participants With Completely Healed Wounds
时间窗: Up to 12 weeks
Assess number of participants with completely healed wounds, defined as 100% epithelialization with no drainage.
Wound Size Change
时间窗: Up to 12 weeks
Assess wound size at specified intervals. Number of wounds with 40% reduction by week 4, 60% by week 8, and 80% by week 12.
次要结局
- Time to Complete Wound Closure(up to 52 week visit (until study completion))
- Visual Analogue Scale (VAS) for Pain(Up to 52 week visit (until study completion))
- Complete Wound Management(up to 52 week visit (until study completion))
- Wound-Related Adverse Events(up to 52 week visit (until study completion))
- Wound Characteristics(up to 52 week visit (until study completion))
- Incidence of Bridging(up to 52 week visit (until study completion))
- Wound Quality of Life (W-QOL)(Up to 52 week visit (until study completion))
- Katz Index of Independence in Activities of Daily Living (KATZ ADL)(Up to 52 week visit (until study completion))