RecruitingNCT06850389

PMCF Investigation of Medical Device ChitoCare® Medical


Sponsor

Primex ehf

Enrollment

214 participants

Start Date

Jun 11, 2025

Study Type

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

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called ChitoCare® medical Healing Spray and a medical device called ChitoCare® medical Wound Healing Gel for people with acne, conditions after dematosurgical procedures, and other related conditions. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEChitoCare® 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.

DEVICEChitoCare® 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06850389


Related Trials