Compressive Device to Prevent Keloïd Scars Recurrence [SCARWARS]

NCT03312166 | Completed DMC

• 1 other identifier: API/2016/75
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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

Keywords

ear lobe; compression; medical device; recurrence

Outcome Measures

Primary Outcomes (1)

• Recurrence of keloid scar

  Recurrence will be assessed during each visit by surgeon

  12 month

Study Arms (1)

Compression device

EXPERIMENTAL

Device: Compression device

Interventions

Compression device DEVICE

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

Compression device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

CHU de Besançon

Besançon, 25000, France

Location

MeSH Terms

Conditions

Keloid; Recurrence

Interventions

Intermittent Pneumatic Compression Devices

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Brice Chatelain, MD

  Centre Hospitalier Universitaire de Besançon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: October 17, 2017
• Study Start: October 3, 2017
• Primary Completion: December 14, 2023
• Study Completion: December 14, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)