Summary
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.
Detailed Description
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.
Eligibility Criteria
Age Range: 18 years to No maximum
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 ≤ 1.3;
2. Toe-Brachial Index (TBI) ≥ 0.6;
3. Transcutaneous Oxygen Measurement (TCOM) ≥ 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.
Interventions
OTHER
Control Dressing + Standard of Care
OTHER
CAMP + Standard of Care