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Completed

NCT Number: NCT03312166

Compressive Device to Prevent Keloïd Scars Recurrence [SCARWARS]

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Besançon

Besançon, 25000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Compression device

Device

interventions on patient are :

  • surgical excision of ear lobe keloid
  • application of compression device on sutured skin

Primary outcomes

  1. Recurrence of keloid scar

    Time frame: 12 month

    Recurrence will be assessed during each visit by surgeon

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Official study title

First Study Evaluating Efficiency and Safety of a Compressive Device to Prevent Keloid Scars Recurrence After Surgery

Acronym: SCARWARS

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Oct 17, 2017
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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