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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03312166
Other study ID # API/2016/75
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 3, 2017
Est. completion date October 10, 2022

Study information

Verified date July 2021
Source Centre Hospitalier Universitaire de Besancon
Contact Gwenael Rolin, PhD
Phone 0033 3 81 21 91 64
Email grolin@chu-besancon.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 27
Est. completion date October 10, 2022
Est. primary completion date October 10, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Compression device
interventions on patient are : surgical excision of ear lobe keloid application of compression device on sutured skin

Locations

Country Name City State
France CHU de Besançon Besançon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recurrence of keloid scar Recurrence will be assessed during each visit by surgeon 12 month
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