47
Participants
Start Date
July 19, 2021
Primary Completion Date
July 15, 2024
Study Completion Date
August 1, 2024
Synthetic Hybrid-Scale Fiber Matrix
A synthetic absorbable skin substitute indicated for use in the local management of wounds. It is made of small synthetic fibers that are designed to be similar to the structure of human skin.
Standard of Care
To ensure off-loading, each patient will be fitted with an off-loading device based on the investigator's decision, e.g. a boot for forefoot and a heel protector for hindfoot. Patients is instructed on how to care for the surgical site, utilize an off-loading device, and keep the surgical site moist and clean. If the wound is dry, a hydrogel category dressing type should be used. If the wound has exudate, an alginate or foam dressing is recommended.
Living Cellular Skin Substitute
An absorbable skin substitute comprised of human and bovine (cow) tissues indicated for use in the local management of wounds.
University of Florida - Jacksonville, Jacksonville
Barry University, Miami Beach
Gundersen Health System, La Crosse
Rush University Medical Center, Chicago
ILD Research Center, Vista
Boston Medical Center, Boston
Lead Sponsor
Acera Surgical, Inc.
INDUSTRY