Compressive Device to Prevent Keloïd Scars Recurrence [SCARWARS]

Centre Hospitalier Universitaire de Besancon

Status

Completed

Conditions

Keloid

Treatments

Device: Compression device

Study type

Interventional

Funder types

Other

Identifiers

NCT03312166

API/2016/75

Details and patient eligibility

About

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 silicon. SCARWARS is a monocentric study. 27 patients will be include and follow during one year. The primary outcome of this study is the number of keloid recurrence after treatment.

Enrollment

31 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.