Compressive Device to Prevent Keloïd Scars Recurrence [SCARWARS] (SCARWARS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Keloid
• Intervention / Treatment: Device: Compression device

• Study Type: Interventional
• Enrollment (Anticipated): 27
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gwenael Rolin, PhD; Phone Number: 0033 3 81 21 91 64; Email: grolin@chu-besancon.fr
• Study Contact Backup: Name: Lihoreau Thomas, Ing; Email: tlihoreau@chu-besancon.fr

Study Locations

• France
  • Besançon, France, 25000
    • Recruiting
    • CHU de Besancon
    • Contact: Thomas Lihoreau, Ing; Email: tlihoreau@chu-besancon.fr
    • Contact: Gwenaël Rolin, PhD; Email: grolin@chu-besancon.fr
    • Principal Investigator: Brice Chatelain, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Compression device	Device: Compression device; interventions on patient are : surgical excision of ear lobe keloid; application of compression device on sutured skin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of keloid scar	Recurrence will be assessed during each visit by surgeon	12 month

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Investigators: Principal Investigator: Brice Chatelain, MD, Centre Hospitalier Universitaire de Besancon

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 3, 2017
• Primary Completion (ANTICIPATED): October 10, 2022
• Study Completion (ANTICIPATED): October 10, 2022

Study Registration Dates

• First Submitted: October 12, 2017
• First Submitted That Met QC Criteria: October 12, 2017
• First Posted (ACTUAL): October 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 30, 2021
• Last Update Submitted That Met QC Criteria: July 29, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: medical device; recurrence; compression; ear lobe
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Connective Tissue Diseases; Fibrosis; Cicatrix; Collagen Diseases; Recurrence; Keloid
• Other Study ID Numbers: API/2016/75

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No