Keloid
Conditions
Keywords
ear lobe, compression, medical device, recurrence
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 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.
Interventions
DEVICECompression device
interventions on patient are : * surgical excision of ear lobe keloid * application of compression device on sutured skin
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of keloid scar | 12 month | Recurrence will be assessed during each visit by surgeon |
Countries
France
Outcome results
None listed