A randomized, open-label, investigational safety evaluation of the Microporous Annealed Particle (MAP) Wound Matrix (TT101) device as a volumetric biomaterial scaffold applied to clean wounds after skin cancer surgery with Mohs micrographic surgery (MMS) compared to control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
The MAP Wound Matrix is indicated for the management of full thickness wounds, including surgical sites, donor skin graft sites, wound dehiscence, lacerations, and draining wounds. The application of MAP Wound Matrix will occur immediately after Mohs surgery once hemostasis has been achieved
DuoDerm is a hydrocolloid dressing will be topically applied to the wound immediately following Mohs surgery according to the manufacturer\'s instructions.
Cal Coast Dermatology
Encino, California, United States
Laser and Skin Surgery Center of Indiana
Indianapolis, Indiana, United States
Studies in Dermatology
Cypress, Texas, United States
Incidence of serious adverse device effects in the treatment group compared to the control group.
Incidence of serious adverse device effects (SADE) (including delays in wound healing and surgical site infections) in subjects treated with MAP Wound Matrix, compared to the control group.
Time frame: Week 0 (treatment) up to Week 24 (End of Study)
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