Post-Market Clinical Follow-Up Study of ChitoCare Medical Devices for Treating Scars, Dermatosurgical Conditions, Dermatitis, and Acne

What this Trial Is About

Researchers are conducting a post-marketing observational clinical investigation to follow up on the ChitoCare4 Medical device. This study aims to confirm the safety and effects of the device as required by European medical device regulations. It focuses on treating skin conditions such as scars, dermatitis, acne, and conditions following dermatosurgical procedures. The study evaluates two forms of the ChitoCare4 medical device a Wound Healing Gel and a Healing Spray. Both contain ChitoClear4 chitosan and are used to treat various acute and chronic wounds and skin conditions. The gel is indicated specifically for scars, post-surgical skin conditions, dermatitis, and acne, while the spray is for wounds and similar skin conditions. Participants will be monitored over a period of 2 to 3 months. Researchers will assess improvements using scales like the Vancouver Scar Scale, the Comprehensive Acne Severity Scale, and a dermatitis severity scale. Safety will be confirmed by monitoring adverse and serious adverse events. Quality of life assessments will also be conducted for adults and children during the study period.

PMCF Investigation of Medical Device ChitoCare® Medical