Status:
COMPLETED
Compressive Device to Prevent Keloïd Scars Recurrence [SCARWARS]
Lead Sponsor:
Centre Hospitalier Universitaire de Besancon
Conditions:
Keloid
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
SCARWARS study deals with the first on-human evaluation of a compressive device dedicated to the prevention of keloïd scars recurrence after surgery. The tested device is made with clinical grade sili...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 3 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2023
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT03312166
Start Date
October 3 2017
End Date
December 14 2023
Last Update
September 19 2024
Active Locations (1)
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1
CHU de Besançon
Besançon, France, 25000