MIRODERM™ for Complex Wounds in an Inpatient Setting
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- The proportion of subjects that have had an autograft or delayed primary closure procedure for the study wound by Week 6.
研究概览
简要总结
This study is being conducted to collect data on the performance of Miromatrix Wound Matrix (MIRODERM) when used in the treatment of complex wounds in an inpatient setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Be at least 18 years old
- •Have a complex study wound which will require an autograft or delayed primary closure procedure and which may or may not include tunneling and/or undermining
- •Have a study wound with a total post-debridement surface area ≥50cm2 and ≤250cm2 with no dimension >25cm, and a minimum depth of ≥0.5cm
- •Have a study wound which is expected to take at least 4 weeks to reach autograft or delayed primary closure using standard care and NPWT
- •Have a study wound that will be treated with NPWT regardless of study participation
- •Be in an inpatient setting
- •Be able and willing to sign the consent form and comply with all study visits and procedures
排除标准
- •Be pregnant or be planning to become pregnant during the study
- •Be contraindicated for NPWT (necrotic tissue with eschar present, untreated osteomyelitis, non-enteric and unexplored fistulas, malignancy in the wound, exposed vasculature, exposed nerves, exposed anastomotic site, exposed organs)
- •Be immunocompromised or at risk of immunosuppression (e.g. be HIV positive, be experiencing organ rejection, be a recent, current, or anticipated chemotherapy recipient) as determined by the Investigator
- •Be taking a Tumor Necrosis Factor (TNF) blocker
- •Be participating in another research study
- •Have a sensitivity to porcine material
- •Have a life expectancy of less than 1 year
- •Have a study wound which is a third degree burn wound
- •Have a study wound that is infected
- •Have a study wound that is a pressure ulcer/wound
- •Have a study wound with sinus tract(s) leading to other open area(s)
- •Have a wound that is being treated or expected to be treated with either HBOT or topical wound oxygen therapy
- •Have a study wound which has been treated with a cellular and/or tissue-based product within last 30 days
研究组 & 干预措施
NPWT Only
Study subjects who are randomized to the control arm will be treated with Negative Pressure Wound Therapy (NPWT) and additional standard care treatments. No cellular or acellular biological tissue scaffold will be allowed for subjects in this study arm for the first 6 weeks of the study. Subjects who are randomized to this arm and who do not experience at least a 50% surface area reduction of the study wound by the 6 week study visit will have the option to cross over into the NPWT + MIRODERM treatment arm.
干预措施: Negative Pressure Wound Therapy (NPWT) (Other)
NPWT Only
Study subjects who are randomized to the control arm will be treated with Negative Pressure Wound Therapy (NPWT) and additional standard care treatments. No cellular or acellular biological tissue scaffold will be allowed for subjects in this study arm for the first 6 weeks of the study. Subjects who are randomized to this arm and who do not experience at least a 50% surface area reduction of the study wound by the 6 week study visit will have the option to cross over into the NPWT + MIRODERM treatment arm.
干预措施: Standard Care (Other)
NPWT + MIRODERM
Subjects in this arm will receive NPWT and standard care, plus application(s) of the MIRODERM product.
干预措施: MIRODERM Application(s) (Other)
NPWT + MIRODERM
Subjects in this arm will receive NPWT and standard care, plus application(s) of the MIRODERM product.
干预措施: Negative Pressure Wound Therapy (NPWT) (Other)
NPWT + MIRODERM
Subjects in this arm will receive NPWT and standard care, plus application(s) of the MIRODERM product.
干预措施: Standard Care (Other)
结局指标
主要结局
The proportion of subjects that have had an autograft or delayed primary closure procedure for the study wound by Week 6.
时间窗: 6 weeks
The primary endpoint is the proportion of subjects that have had an autograft or delayed primary closure procedure for the study wound by the 6 week visit.
次要结局
未报告次要终点