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PMCF Investigation of Medical Device ChitoCare® Medical
Sponsor: Primex ehf
Summary
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
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
214
Start Date
2025-06-11
Completion Date
2025-12
Last Updated
2025-08-17
Healthy Volunteers
Not specified
Interventions
ChitoCare® medical Wound Healing Gel
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
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.
Locations (2)
Dermatovenerology department, FN Motol
Prague, Czechia
Dermatology of Prof. Hercogova
Prague, Czechia