Compressive Device to Prevent Keloïd Scars Recurrence [SCARWARS]

Last updated: September 5, 2024
Sponsor: Centre Hospitalier Universitaire de Besancon
Overall Status: Completed

Phase

N/A

Condition

Scar Tissue

Treatment

Compression device

Clinical Study ID

NCT03312166
API/2016/75
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 bythe study and agrees to participate in the study and comply with the requirementsand limitations inherent in this study;

  • Patient with French social insurance.

Exclusion

Exclusion Criteria:

  • Patient with cutaneous dermatosis or other skin pathology able to interfere withevaluated 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 bythe investigator;

  • Patient without health insurance;

  • The patient is in the period of exclusion of another study.

Study Design

Total Participants: 31
Treatment Group(s): 1
Primary Treatment: Compression device
Phase:
Study Start date:
October 03, 2017
Estimated Completion Date:
December 14, 2023

Connect with a study center

  • CHU de Besançon

    Besançon, 25000
    France

    Site Not Available

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