Compressive Device to Prevent Keloïd Scars Recurrence [SCARWARS]

Keloid Clinical Trial

— SCARWARS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03312166
• Other study ID #: API/2016/75
• Status: Recruiting
• Phase: N/A
• Start date: October 3, 2017
• Est. completion date: October 10, 2022

Study information

• Verified date: July 2021
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Gwenael Rolin, PhD
• Phone: 0033 3 81 21 91 64
• Email: grolin[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: October 10, 2022
• Est. primary completion date: October 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Keloid
• Recurrence

Intervention

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

Locations

Country	Name	City	State
France	CHU de Besançon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of keloid scar	Recurrence will be assessed during each visit by surgeon	12 month