NCT07695389尚未招募4 期
A Multicenter, Prospective, Randomized Controlled Clinical Trial Assessing the Efficacy of a Novel Cellular, Acellular, Matrix-like Product (CAMP) Plus Standard of Care Versus Standard of Care Alone in the Management of Post-Mohs Micrographic Surgery Defects.
BioLab Holdings0 个研究点目标入组 160 人开始时间: 2026年7月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 主要终点
- Complete Wound Closure
研究概览
简要总结
A multicenter, prospective, randomized controlled clinical trial assessing the efficacy of a novel cellular, acellular, matrix-like product (CAMP) plus standard of sare versus standard of sare slone in the management of post-mohs micrographic surgery defects.
详细描述
This study will utilize a Prospective, Multicenter, Randomized Controlled Clinical Trial design.
Subjects will be adult patients undergoing Mohs micrographic surgery with resulting post-excisional defects suitable for healing by secondary intention or management with a topical matrix-like product.
Subjects will be randomized to receive:
- CAMP plus Standard of Care (SOC), or
- Control Dressing plus SOC. Randomization will occur after confirmation of final Mohs stage and measurement of the post-excisional defect.
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
- •The potential subject must be at least 18 years of age or older.
- •The potential subject must have undergone Mohs micrographic surgery for a cutaneous malignancy (e.g., basal cell carcinoma, or squamous cell carcinoma).
- •The potential subject must have a post-Mohs surgical defect that is suitable for treatment with a CAMP product or healing by secondary intention.
- •The surgical site has received standard Mohs excision and hemostasis with no requirement for immediate flap or graft reconstruction as determined by the treating surgeon.
- •If the surgical defect is on the lower extremity, the limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:
- •Ankle-Brachial Index (ABI) between 0.7 and ≤ 1.3;
- •Toe-Brachial Index (TBI) ≥ 0.6;
- •Transcutaneous Oxygen Measurement (TCOM) ≥ 40 mmHg;
- •Pulse Volume Recording (PVR): biphasic.
- •If the subject has multiple Mohs defects, they must be separated by at least 2 cm. The largest defect satisfying the inclusion and
排除标准
- •will be designated as the target wound.
- •The potential subject must agree to attend the weekly study visits required by the protocol.
- •The potential subject must be willing and able to participate in the informed consent process.
- •Exclusion Criteria:
- •The potential subject is known to have a life expectancy of < 6 months.
- •The potential subject's target wound is not secondary to a Mohs excision. -
- •. The target wound is infected or there is cellulitis in the surrounding skin.
- •The target wound:
- •Exposes tendon, bone, or joint space, and/or[MM6.1][RB6.2]
- •Requires immediate complex flap or graft reconstruction in the judgment of the surgeon.
- •The potential subject has participated in a clinical trial involving treatment with an investigational product within the previous 30 days.
- •The potential subject has glycated hemoglobin (HbA1c) greater than 10% within 3 months of the initial screening visit.
- •The potential subject, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
结局指标
主要结局
Complete Wound Closure
时间窗: 1-6 Weeks
The percentage of target wounds achieving complete wound closure in 6 weeks.
次要结局
- Time to Closure(1-6 Weeks)
- Percentage Area Reduction(1-6 weeks)
- Procedure-Related Adverse Events(1-6 Weeks)
- Wound Volume Reduction(1-6 Weeks)
- Product or Procedure Adverse Events(1-6 Weeks)
- Numeric Pain Scale(1-6 weeks)
- Economic Outcomes(1-6 Weeks)
- Quality of Life(1- 6 Weeks)
- Scare and Cosmetic Outcomes(12 Months)
- Time to Complete Granulation Tissue(1-6 Weeks)
研究者
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