Compressive Device to Prevent Keloïd Scars Recurrence [SCARWARS]

NCT03312166 — Not applicable, Completed, 31 participants, Centre Hospitalier Universitaire de Besancon

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

RegistryNCT03312166, acronym SCARWARS
StatusCompleted
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, prevention
Enrollment31 (Actual)
SponsorCentre Hospitalier Universitaire de Besancon (Other)
ConditionsKeloid
InterventionsCompression device (Device)
Datesstart 2017-10-03, primary completion 2023-12-14, completion 2023-12-14, first posted 2017-10-17, last updated 2024-09-19
Locations1 site in France

Related Papers Related Patents Related Grants Related Experts
All trials for Keloid All trials of Compression device

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Compression deviceExperimentalDevice: Compression device
  • Compression device (Device): interventions on patient are : * surgical excision of ear lobe keloid * application of compression device on sutured skin

+Outcome measures

Primary outcomes

  • Recurrence of keloid scar [12 month]: Recurrence will be assessed during each visit by surgeon

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

FacilityCityCountryStatus
CHU de BesançonBesançonFrance

+Investigators