Study of Electrospun Fiber Matrix Restrata for Healing Surgical Wounds After Removal of Skin Cancer

What this Trial Is About

This observational prospective study evaluates the healing process of wounds created by surgical removal of malignant skin tumors. It focuses on measuring the time from the initial surgery and application of a synthetic electrospun fiber matrix to the complete formation of new tissue in the wound bed. The study is conducted by Acera Surgical, Inc. and monitors healing outcomes in patients with surgical wounds from skin cancer removal. Participants receive treatment with the synthetic electrospun fiber matrix applied immediately after their surgical tumor removal. The study observes wound healing progress without assigning participants to comparison groups. The main treatment period includes weekly assessments until the wound bed fully granulates or up to six weeks after surgery. Additional healing measures are tracked up to 16 weeks post-surgery. Participants are involved in weekly evaluations of wound healing, pain levels, and skin graft or tissue flap success rates as applicable. The primary outcome is time to wound bed granulation, with secondary outcomes including time to complete wound closure, patient pain, and graft or flap take rates. The study continues until wound healing is achieved or for a maximum of 16 weeks, with ongoing assessments to understand healing timelines and treatment effects.

A Prospective, Single-arm, Clinical Trial of Electrospun Fiber Matrix (Restrata) in the Treatment of Surgical Defects Secondary to Resection of Malignant Cutaneous Neoplasms