Microneedling Therapy With or Without Amnion Bilayer Sheeting on Scar Tissue

The Comparison of Microneedling Therapy With or Without Amnion Bilayer Sheeting on Post-Burn Hypertrophic Scar Tissue

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.

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.

In this study, one scar in one subject, will be divided into two areas, one-half of the scar will receive an intervention of microneedling, and the other half will receive microneedling+amnion bilayer. Hence, one subject will receive both interventions at the same time

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

Microneedling is conducted following a three-week application of tretinoin cream. Then, scar tissue that has been treated with microneedling is covered with amnion bilayer for 72 hours.

Microneedling is conducted following a three-week application of tretinoin cream. Then, scar tissue that has been treated with microneedling is covered with an antibacterial gauze dressing.

Using Patient and Observer Scar Assessment Scale (Patients scored from 1-10 in pain, itch, color, stiffness, thickness and irregularity of their scar, observer gives score on vascularity, pigmentation, thickness, relief, pliability, and surface area)

Using Modified Vancouver Scar Scale (Evaluating pigmentation (score 0-3), vascularity (0-3), pliability (0-5), height (0-5))

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