PMCF Investigation of Medical Device ChitoCare® Medical

NCT ID: NCT06850389

Last Updated: 2025-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

214 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-11

Study Completion Date

2025-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Dermatitis Acne Conditions After Dematosurgical Procedures Scars

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Porta Medica

UNKNOWN

Sponsor Role collaborator

Primex ehf

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dermatovenerology department, FN Motol

Prague, , Czechia

Site Status RECRUITING

Dermatology of Prof. Hercogova

Prague, , Czechia

Site Status RECRUITING

Countries

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Czechia

Central Contacts

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Craig Fraser, PhD

Role: CONTACT

+354 846 1912

Facility Contacts

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Alena Machovcová,, MD

Role: primary

+420 224 438 770

Jana Třešňák Hercogová,, MD

Role: primary

+420 246 035 111

Other Identifiers

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CHITODERM

Identifier Type: -

Identifier Source: org_study_id

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