Compressive Device to Prevent Keloïd Scars Recurrence [SCARWARS]

Sponsor

Centre Hospitalier Universitaire de Besancon (Other)

Overall Status

Recruiting

CT.gov ID

NCT03312166

Collaborator

(none)

Enrollment

Location

Arm

60.2

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Keloid	Device: Compression device	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

27 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 3, 2017

Anticipated Primary Completion Date :

Oct 10, 2022

Anticipated Study Completion Date :

Oct 10, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.