Microneedling for Burn Hypertrophic Scars

NCT ID: NCT05423613

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-22
• Study Completion Date: 2026-06-20

Brief Summary

Approximately 33 to 91% of severe burn victims will develop hypertrophic scars. Hypertrophic scars are defined as erythematous (red), raised and rigid scars that can cause pain and itching, among other things. They cause psychological distress and affect the quality of life of burn victims. Microneedling is a technique that uses an electrical device to create hundreds of microchannels that penetrate the skin layers. This study is interested in determining the effectiveness of microneedling in improving the pliability, thickness and erythema of hypertrophic scars. Each scar will receive up to 5 ACS-pen treatments followed by the application of cortisone (triamcinolone acetonide). Knowing that microneedling increases the absorption of products applied to the skin by about 80%, it is logical to think that creating these channels to the dermis and applying cortisone afterwards would have a beneficial effect on the hypertrophic scars of these patients.

Detailed Description

Patients will receive microneedling once every six weeks for a maximum of five treatments

Conditions

Burn Scar

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Microneedling treated scar

Microneedling

Group Type: EXPERIMENTAL

Microneedling

Intervention Type: PROCEDURE

A 5% lidocaine anesthetic cream will be applied to the scar to be treated and will be wrapped with an occlusive dressing (saran wrap) for 30 minutes prior to the procedure. The same scar will be subjected to the ACS-Pen treatment at a depth of 1.5 mm or less depending on the results of the thickness measurement performed prior to treatment. Within 5 minutes after the microneedling treatment, a thin layer of triamcinolone acetonide and 2% xylocaine (1:3 ratio) suspension will be spread over the scar. The physician will then gently massage the product into the microneedling columns. The same amount will be used for each subsequent treatment. The patient will also be given a small amount of hydrocortisone 2.5% (low potency corticosteroid) to be applied to the treated site at 12 hours and 24 hours post-treatment.

Control scar

No intervention, standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Microneedling

A 5% lidocaine anesthetic cream will be applied to the scar to be treated and will be wrapped with an occlusive dressing (saran wrap) for 30 minutes prior to the procedure. The same scar will be subjected to the ACS-Pen treatment at a depth of 1.5 mm or less depending on the results of the thickness measurement performed prior to treatment. Within 5 minutes after the microneedling treatment, a thin layer of triamcinolone acetonide and 2% xylocaine (1:3 ratio) suspension will be spread over the scar. The physician will then gently massage the product into the microneedling columns. The same amount will be used for each subsequent treatment. The patient will also be given a small amount of hydrocortisone 2.5% (low potency corticosteroid) to be applied to the treated site at 12 hours and 24 hours post-treatment.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Any gender or race
• 16 years of age or older
• Have at least 2 HSc that meet the clinical criteria for HSc
• Provide written informed consent.

Exclusion Criteria

• Patients with keloid scars
• Mature scar site
• A psychiatric condition or cognitive impairment that interferes with their ability to follow the treatment protocol
• Dermatological conditions (i.e. psoriasis, eczema, etc.) in the area of the evaluation site
• An allergy to ultrasound gel
• On anticoagulant medications
• Inability to understand English or French.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Bernadette Nedelec

Full professor, McGill University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Villa Medica Rehabilitation Hospital

Montreal, , Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Bernadette Nedelec

Role: CONTACT

bernadette.nedelec@mcgill.ca

514-398-1275

Facility Contacts

Bernadette Nedelec

Role: primary

bernadette.nedelec@mcgill.ca

Other Identifiers

20.184

Identifier Type: -

Identifier Source: org_study_id