Compressive Device to Prevent Keloïd Scars Recurrence [SCARWARS]

NCT ID: NCT03312166

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-03
• Study Completion Date: 2023-12-14

Brief 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.

Conditions

Keloid

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Compression device

Group Type: EXPERIMENTAL

Compression device

Intervention Type: DEVICE

interventions on patient are :

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

Interventions

Compression device

interventions on patient are :

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brice Chatelain, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Besançon

Locations

CHU de Besançon

Besançon, , France

Countries

France

Other Identifiers

API/2016/75

Identifier Type: -

Identifier Source: org_study_id