NCT06600152已完成不适用
A Randomized, Open-label, Investigational Safety Evaluation of the Microporous Annealed Particle (MAP) Wound Matrix (TT101) Device as a Volumetric Biomaterial Scaffold Applied to Clean Wounds After Skin Cancer Surgery With Mohs Micrographic Surgery (MMS) Compared to Control.
Tempo Therapeutics6 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年8月26日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 6
- 主要终点
- Incidence of serious adverse device effects in the treatment group compared to the control group.
研究概览
简要总结
A randomized, open-label, investigational safety evaluation of the Microporous Annealed Particle (MAP) Wound Matrix (TT101) device as a volumetric biomaterial scaffold applied to clean wounds after skin cancer surgery with Mohs micrographic surgery (MMS) compared to control.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing to undergo the written informed consent process prior to enrollment in this study.
- •At least 22 years of age at screening.
- •Has non-melanoma skin cancer and be scheduled for skin cancer surgery with Mohs micrographic surgery on a location suitable for secondary intention healing.
- •Resulting surgical wound after Mohs micrographic surgery must be at least 1 cm and no more than 4 cm in diameter (or surface area of at least 0.8 cm2 and no more than 12.6 cm2).
- •Resulting surgical wound after Mohs micrographic surgery must be full thickness.
- •Willing to return for all required follow-up visits.
- •Willing to follow the instructions of the Principal Investigator.
排除标准
- •_ Has a confirmed diagnosis of clinically significant peripheral neuropathy.
- •Has uncontrolled Type I or Type II diabetes and HbA1c values greater than 8.0% within the last 6 months.
- •Has a known infection in the area of the Mohs micrographic surgery.
- •Has a known allergy to any of the components of the TT101 Device.
- •Is an active daily cigarette smoker.
- •Is pregnant or lactating.
- •Is a woman of child-bearing potential who is unwilling to avoid pregnancy or use an appropriate form of birth control (adequate birth control methods are defined as: topical, oral, implantable, or injectable contraceptives; spermicide in conjunction with a barrier such as a condom or diaphragm; IUD; or surgical sterilization of partner).
- •Has clinical evidence of Peripheral Vascular Disease (PVD) in the form of grade 2 pitting Edema or higher.
- •Has been diagnosed with a surgical or wound site infection within the last 6-months.
- •Has been diagnosed with chronic ulcer or wound within the last 12- months.
- •Has a remote active infection concurrent with having the Mohs micrographic surgery.
- •Per Investigator's discretion the subject is not appropriate for inclusion in the trial.
研究组 & 干预措施
Microporous Annealed Particle (MAP) Wound Matrix
Experimental
The Microporous Annealed Particle (MAP) Wound Matrix device will be topically applied to the wound immediately following Mohs micrographic surgery (MMS).
干预措施: MAP Wound Matrix (Device)
Hydrocolloid dressing (DuoDerm)
Active Comparator
A hydrocolloid (DuoDerm) will be topically applied to the wound immediately following Mohs micrographic surgery.
干预措施: DuoDerm (Device)
结局指标
主要结局
Incidence of serious adverse device effects in the treatment group compared to the control group.
时间窗: Week 0 (treatment) up to Week 24 (End of Study)
Incidence of serious adverse device effects (SADE) (including delays in wound healing and surgical site infections) in subjects treated with MAP Wound Matrix, compared to the control group.
次要结局
未报告次要终点
研究者
研究点 (6)
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