This is a post-marketing observational clinical investigation conducted as part of the post-market clinical follow-up of ChitoCare® Medical, aimed to confirm safety and efficacy according to the requirements of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, for the following indications: Gel - scars, conditions after dermatosurgical procedures, dermatitis, acne Spray - conditions after dermatosurgical procedures, dermatitis, acne
Study Type
OBSERVATIONAL
Enrollment
214
ChitoCare® medical Wound Healing Gel is a medical device containing ChitoClear® chitosan. The device is indicated for the treatment of acute and chronic wounds and other skin conditions, including partial thickness burn wounds.
ChitoCare® medical Healing Spray is a medical device containing ChitoClear® chitosan. The device is indicated for the treatment of acute wounds and other skin conditions.
Dermatovenerology department, FN Motol
Prague, Czechia
RECRUITINGDermatology of Prof. Hercogova
Prague, Czechia
RECRUITINGSignificant improvement in Vancouver Scar Scale (VSS)
For scars and conditions after dermatosurgical procedures, efficacy is defined as a significant improvement in Vancouver Scar Scale (VSS) scores from baseline after 3 months of treatment.
Time frame: 3 months
Significant improvement in Comprehensive Acne Severity Scale (CASS)
For acne, efficacy is defined as a significant improvement in the severity rating of patients' acne using the Comprehensive Acne Severity Scale (CASS) from baseline after 2 months of treatment.
Time frame: 2 months
Significant improvement in dermatitis severity scale
For dermatitis, efficacy is defined as a significant improvement in the severity dermatitis severity scale after 2 months of treatment.
Time frame: 2 months
Confirmation of safety (adverse events)
Safety will be confirmed when less than 5% of subjects report an adverse event when all participants have completed the trial.
Time frame: 2-3 months
Confirmation of safety (serious adverse events)
Safety will be confirmed when less than 1% of subjects report a serious adverse event when all participants have completed the trial.
Time frame: 2-3 months
Quality of life assessment (adults)
Quality of life will be assessed in adults using the Dermatology Life Quality Index (DLQI) questionnaire. Improvements in quality of life from baseline will be reported.
Time frame: 2-3 months
Quality of life assessment (children)
In children, quality of life will be assessed using the pediatric version of the Dermatology Life Quality Index - the Childhood Dermatology Life Quality Index (CDLQI) questionnaire. Improvements in quality of life from baseline will be reported.
Time frame: 2-3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.