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CompletedNCT03312166SCARWARSUpdated Sep 19, 2024

Compressive Device to Prevent Keloïd Scars Recurrence [SCARWARS]

An interventional study of Compression device in Keloid, sponsored by Centre Hospitalier Universitaire de Besancon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Centre Hospitalier Universitaire de Besancon · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Keloid

Keywords

  • ear lobe
  • compression
  • medical device
  • recurrence
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    Compression device

    Device: Compression device

Interventions

  • DeviceCompression device

    interventions on patient are : * surgical excision of ear lobe keloid * application of compression device on sutured skin

05

What researchers measure

Primary outcomes

  1. Recurrence of keloid scar

    Recurrence will be assessed during each visit by surgeon

    Time frame: 12 month

06

Study locations

1 site
  • CHU de Besançon
    Besançon, 25000, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03312166
Lead sponsor
Centre Hospitalier Universitaire de Besancon
Responsible party
Sponsor
First posted
Oct 17, 2017
Start date
Oct 3, 2017
Primary completion
Dec 14, 2023
Completion
Dec 14, 2023
Last update
Sep 19, 2024

Study contacts

Brice Chatelain, MD
principal investigator · Centre Hospitalier Universitaire de Besançon

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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