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

Primary Purpose

Keloid

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Compression device

About this trial

This is an interventional prevention trial for Keloid focused on measuring ear lobe, compression, medical device, recurrence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

CHU de BesançonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Compression device

Arm Description

Outcomes

Primary Outcome Measures

Recurrence of keloid scar

Recurrence will be assessed during each visit by surgeon

Secondary Outcome Measures

Full Information

NCT ID

NCT03312166

First Posted

October 12, 2017

Last Updated

July 29, 2021

Sponsor

Centre Hospitalier Universitaire de Besancon

1. Study Identification

Unique Protocol Identification Number

NCT03312166

Brief Title

Compressive Device to Prevent Keloïd Scars Recurrence [SCARWARS]

Acronym

SCARWARS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Unknown status

Study Start Date

October 3, 2017 (Actual)

Primary Completion Date

October 10, 2022 (Anticipated)

Study Completion Date

October 10, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Besancon

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Keloid

Keywords

ear lobe, compression, medical device, recurrence

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

27 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Compression device

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Compression device

Intervention Description

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

Primary Outcome Measure Information:

Title

Recurrence of keloid scar

Description

Recurrence will be assessed during each visit by surgeon

Time Frame

12 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gwenael Rolin, PhD

Phone

0033 3 81 21 91 64

grolin@chu-besancon.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Lihoreau Thomas, Ing

tlihoreau@chu-besancon.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brice Chatelain, MD

Organizational Affiliation

Centre Hospitalier Universitaire de Besançon

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU de Besançon

City

Besançon

ZIP/Postal Code

25000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Thomas Lihoreau, Ing

tlihoreau@chu-besancon.fr

First Name & Middle Initial & Last Name & Degree

Gwenaël Rolin, PhD

grolin@chu-besancon.fr

First Name & Middle Initial & Last Name & Degree

Brice Chatelain, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Compressive Device to Prevent Keloïd Scars Recurrence [SCARWARS]

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