Microneedling Therapy With or Without Amnion Bilayer Sheeting on Scar Tissue

Dr.dr.Irma Bernadette, SpKK (K)

Status: Unknown

Conditions: Burn Scar; Scars, Hypertrophic

Treatments: Procedure: Microoneedling; Procedure: Microoneedling and Amnion Bilayer

Study type: Interventional

Funder types: Other

Identifiers

NCT04995302

MicroneedlingScar

Details and patient eligibility

About

The aim of this study is to compare the outcome of microneedling therapy with or without amnion bilayer sheeting on post-burn hypertrophic scar tissue. A clinical trial will be conducted with 17 samples, from September to December 2021.

Full description

High degree burn injuries commonly result in abnormal scar formation, and therapy for this hypertrophic scar remains a challenge. For years, microoneedling has been used for treating hypertrophic scars, and an addition of amnion bilayer sheeting is expected to provide a more favorable outcome. This study aims to compare microneedling therapy with or without amnion bilayer sheeting on post-burn hypertrophic scars tissue. This is an interventional study with 17 samples, aged 18-50 years old. Therapeutic outcomes will be evaluated using visual analog scale, degree of erythema, patient's subjective evaluation, dermoscope, biopsy, and skin ultrasound.

Enrollment: 17 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patients, aged 18-50 years old
• Patients with post-burn, mature hypertrophic scars, localized in any areas other than the face, with a minimum of 5 cm in diameter.
• Patients are willing to participate in the study and sign an informed consent form

Exclusion criteria

• Patients with scars less than 5 cm in diameter
• Patients with scars localized solely in the face
• Hypertrophic scars with keloid
• Patients with comorbidities

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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17 participants in 2 patient groups, including a placebo group

Microneedling and Amnion Bilayer

Active Comparator group

Description:

Microneedling is a dermaroller procedure that uses small needles to prick the skin. Amnion bilayer is used as an additional therapy after microneedling therapy.

Treatment:

Procedure: Microoneedling and Amnion Bilayer

Microneedling

Placebo Comparator group

Description:

Microneedling is a dermaroller procedure that uses small needles to prick the skin.

Treatment:

Procedure: Microoneedling