PMCF Investigation of Medical Device ChitoCare® Medical
Primex ehf
214 participants
Jun 11, 2025
OBSERVATIONAL
Conditions
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
Eligibility
Inclusion Criteria4
- Gel - scars, conditions after dermatosurgical procedures, dermatitis, acne
- Spray - conditions after dermatosurgical procedures, dermatitis, acne
- The criteria for exclusion are fully according to contraindications:
- Allergy to any of the ingredients of the product
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Interventions
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.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06850389