CompletedNot Applicable

Compressive Device to Prevent Keloïd Scars Recurrence [SCARWARS]

France31 participantsStarted 2017-10-03

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Recurrence of keloid scar

Timeframe: 12 month

Trial details

NCT IDNCT03312166

SponsorCentre Hospitalier Universitaire de Besancon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-14

View on ClinicalTrials.gov More Keloid trials