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.

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Control Dressing + Standard of Care
  Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 6 weeks, whichever occurs first.
• Другое CAMP + Standard of Care
  Participants will receive weekly applications of caregraFT™ and Standard of Care until ulcer closure, or a maximum of 6 weeks, whichever occurs first.

Первичные конечные точки

• Complete Wound Closure [Срок оценки: 1-6 Weeks]

Вторичные конечные точки (10)

• Time to Closure [Срок оценки: 1-6 Weeks]
• Percentage Area Reduction [Срок оценки: 1-6 weeks]
• Procedure-Related Adverse Events [Срок оценки: 1-6 Weeks]
• Wound Volume Reduction [Срок оценки: 1-6 Weeks]
• Product or Procedure Adverse Events [Срок оценки: 1-6 Weeks]
• Numeric Pain Scale [Срок оценки: 1-6 weeks]
• Economic Outcomes [Срок оценки: 1-6 Weeks]
• Quality of Life [Срок оценки: 1- 6 Weeks]
• Scare and Cosmetic Outcomes [Срок оценки: 12 Months]
• Time to Complete Granulation Tissue [Срок оценки: 1-6 Weeks]

Критерии участия

Критерии включения

• 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 exclusion criteria 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07695389 · To be determined

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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