MedTrace Logo

PMCF Investigation of Medical Device ChitoCare® Medical

NCT06850389 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 214

Last updated 2025-08-17

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Porta Medica

    collaborator UNKNOWN

  • Primex ehf

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-11
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Czechia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06850389 on ClinicalTrials.gov