Registry of Myriad™ Utilization in Soft Tissue Reconstruction Procedures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 15
- 主要终点
- Proportion of participants with treatment emergent adverse events during the study
研究概览
简要总结
This is an observational study designed to evaluate the safety and clinical outcomes of Myriad™ in soft tissue reconstruction procedures. The study will enroll participants who are undergoing a surgical procedure, where the attending physician will use Myriad™ as part of the surgical intervention.
详细描述
This is an observational, multi-center, single arm, Phase IV study, designed to evaluate the safety and clinical outcomes of Matrix and Morcells in soft tissue reconstruction procedures.
The study is a registry study and will enroll participants who are undergoing a surgical procedure, and where the attending physician will use Myriad Matrix™ and/or Morcells™ as part of the surgical intervention.
Participants enrolled in the study will be undergoing a range of surgical procedures involving the reconstruction of soft tissues, including but not limited to:
- Abdominal dehiscence
- Necrotizing soft tissue infection (NSTI)
- Lower extremity complex non-healing wounds (limb salvage)
- Pilonidal sinus disease
- Anal fistula
- Hidradenitis suppurativa reconstruction
- Pressure injury reconstruction
Other procedure types may be included at the discretion of the Investigator/Research Team.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide written informed consent and to comply with the requirements of Clinical Investigational Plan
- •Male or female patients aged 18 years or above
- •Patients where Matrix and/or Morcells were used as part of their soft tissue reconstruction procedure
- •Subject that are willing and able to comply with all aspects of the treatment and evaluation schedule
排除标准
- •Patients with known sensitivity to ovine (sheep) derived material
- •Patients with full thickness ('third degree') burns
- •Patients with wounds with uncontrolled clinical infection (CDC Contamination Grade=4)
- •Any medical condition or serious intercurrent illness that, in the opinion of the investigator, may make it undesirable for the patient to participate in the study
- •Patient is currently participating or has participated in another clinical study within past 30 days prior to enrollment
- •Pregnant or lactating women
- •Any subject who, at the discretion of the Investigator, is not suitable for inclusion in the study
研究组 & 干预措施
Myriad™
Ovine forestomach matrix sheet graft and morselized extracellular matrix
干预措施: Myriad Matrix™ and Myriad Morcells™ (Device)
结局指标
主要结局
Proportion of participants with treatment emergent adverse events during the study
时间窗: 3 years
Nature, frequency, and severity of adverse events
次要结局
- Time (weeks) to 100% granulation(Up to 3 months)
- Time (weeks) to complete healing(Up to 52 weeks)
- Percentage of surgical complications(Up to 3 months)
- Percentage of split thickness skin graft take at 1 week post Matrix™ application(1 week post application)