Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2025-12-24 @ 4:26 PM
NCT ID:
NCT03312166
Eligibility Criteria:
Inclusion Criteria:
* Patient over 18 yo;
* Patient with aer lobe keloid;
* Patient with an indication of reconstructive surgery;
* Signature of informed consent from the patient;
* Indication that the subject has understood the purpose and procedures required by the study and agrees to participate in the study and comply with the requirements and limitations inherent in this study;
* Patient with French social insurance.
Exclusion Criteria:
* Patient with cutaneous dermatosis or other skin pathology able to interfere with evaluated parameter (recurrence and healing quality);
* Patient with know nickel allergy;
* Patient with know silicon allergy;
* Pregnant women;
* Legal incapacity or limited legal capacity;
* Patient unlikely to cooperate in the study and / or low cooperation anticipated by the investigator;
* Patient without health insurance;
* The patient is in the period of exclusion of another study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03312166
Study Brief:
Protocol Section:
NCT03312166