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.
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.
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.
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.
Parallel
Control Dressing + Standard of Care
Other interventionBeginning 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.
CAMP + Standard of Care
Other interventionParticipants will receive weekly applications of Membrane Wrap-Lite 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 to Closure
Time to closure for the target wound.
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.
Procedure-Related Adverse Events
The number of product- or procedure-related adverse events.
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.
Change in Perfusion
Changes in local perfusion at the surgical site over the 6-week treatment period, assessed via near-infrared spectroscopy.
Rate of Recurrence
The rate of recurrence within 12 months of closure when applicable.
Click on the lead sponsor to view all of their trials.
BioLab Holdings
Lead sponsor
SerenaGroup, Inc.
Collaborator
