PMCF Investigation of Medical Device ChitoCare® Medical
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ChitoCare® medical Wound Healing Gel, ChitoCare® medical Healing Spray.
- Who it may be relevant to
- Registry conditions: Dermatitis, Acne, Conditions After Dematosurgical Procedures, Scars. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Czechia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Device 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. - Device 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.
Primary outcome measures
- Significant improvement in Vancouver Scar Scale (VSS) [Time frame: 3 months]
- Significant improvement in Comprehensive Acne Severity Scale (CASS) [Time frame: 2 months]
- Significant improvement in dermatitis severity scale [Time frame: 2 months]
Secondary outcome measures (4)
- Confirmation of safety (adverse events) [Time frame: 2-3 months]
- Confirmation of safety (serious adverse events) [Time frame: 2-3 months]
- Quality of life assessment (adults) [Time frame: 2-3 months]
- Quality of life assessment (children) [Time frame: 2-3 months]
Eligibility criteria
The inclusion criteria are fully according to indications:
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-only
Study locations
Czechia · 2 centers
- Dermatovenerology department, FN Motol — Prague
- Dermatology of Prof. Hercogova — Prague
Identifiers
NCT: NCT06850389 · CHITODERM