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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
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.
Participants will receive weekly applications of caregraFT™ and Standard of Care until ulcer closure, or a maximum of 6 weeks, whichever occurs first.
Complete Wound Closure
The percentage of target wounds achieving complete wound closure in 6 weeks.
Time frame: 1-6 Weeks
Time to Closure
Time to closure for the target wound.
Time frame: 1-6 Weeks
Percentage Area Reduction
Percentage wound area reduction from TV-1 to TV-6 measured weekly with digital photographic planimetry using imaging device and physical examination.
Time frame: 1-6 weeks
Procedure-Related Adverse Events
The number of product- or procedure-related adverse events.
Time frame: 1-6 Weeks
Wound Volume Reduction
Percentage wound volume reduction from TV-1 to TV-6 measured weekly with digital photographic planimetry using imaging device and physical examination.
Time frame: 1-6 Weeks
Product or Procedure Adverse Events
The number of product- or procedure-related adverse events.
Time frame: 1-6 Weeks
Numeric Pain Scale
Change in pain at the target wound site assessed using a numeric pain scale. 0 being no pain and 10 being the worst pain imaginable.
Time frame: 1-6 weeks
Economic Outcomes
Health economic outcomes, including direct and indirect cost of care.
Time frame: 1-6 Weeks
Quality of Life
Change in quality of life, using the Wound Quality of Life questionnaire. \[Time frame: TV-1, TV-4, TV-6/final visit\].
Time frame: 1- 6 Weeks
Scare and Cosmetic Outcomes
Scar and cosmetic outcomes at 12 months using the Patient and Observer Scar Assessment Scale (POSAS). 0 being normal and 10 being very different.
Time frame: 12 Months
Time to Complete Granulation Tissue
Time to complete granulation tissue confirmed by independent assessment.
Time frame: 1-6 Weeks
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