Compressive Device to Prevent Keloïd Scars Recurrence [SCARWARS]

Not Applicable

• Conditions: Keloid
• Interventions: Device: Compression device

• Registration Number: NCT03312166
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-03
• Study First Submitted: 2017-10-12
• Study First Submitted QC: 2017-10-12
• Study First Posted: 2017-10-17
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-29
• Last Update Posted: 2021-07-30
• Primary Completion: 2022-10-10
• Study Completion: 2022-10-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 27

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Compression device	Compression device	-

Primary Outcome Measures

Name	Time	Method
Recurrence of keloid scar	12 month	Recurrence will be assessed during each visit by surgeon

Trial Locations

Locations (1)

CHU de Besançon; 🇫🇷 Besançon, France