NCT06850389

PMCF Investigation of Medical Device ChitoCare® Medical

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 214 (estimated)
• Sponsor: Primex ehf · Industry
• Sex: All
• Age: —
• Healthy volunteers: —

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

Conditions

• Dermatitis
• Acne
• Conditions After Dematosurgical Procedures
• Scars

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-06-11
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2025-02-27
• Last updated: 2025-08-17

Locations

2 sites across 1 country: Czechia