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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.

RecruitingNAAges 18 Years - anyAllBioLab Holdings
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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: 1. Ankle-Brachial Index (ABI) between 0.7 and โ‰ค 1.3; 2. Toe-Brachial Index (TBI) โ‰ฅ 0.6; 3. Transcutaneous Oxygen Measurement (TCOM) โ‰ฅ 40 mmHg; 4. 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. 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: 1. Exposes tendon, bone, or joint space, and/or 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.
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What it tests

  • Control Dressing + Standard of Care
  • CAMP + Standard of Care
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Where

1 site
Southside Dermatology Mohs and Skin Surgery
Tulsa, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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