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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
17
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.
dr. Cipto Mangunkusumo Hospital
Jakarta, Jakarta Pusat, Indonesia
Change in Subjective Pain in one month
Using Visual Analog Scale (0-10, 0 indicates no pain and 10 indicates severe pain)
Time frame: Baseline, day 7, day 30
Change in Erythema Degree in one month
Using Erythema score (0-4, 0 indicates no erythema and 4 indicates severe erythema)
Time frame: Baseline, day 7, day 30
Change in Dermoscopy Evaluation in one month
Qualitative description of blood vessel structure, pigmentation density and erythema
Time frame: Baseline, day 7 , day 30
Change in Biopsy Evaluation in one month
Descriptive evaluation using HE staining
Time frame: Baseline, Day 7 and day 30
Change in Skin Thickness in one month
Evaluation with USG of epidermal and dermal layer (in pixels)
Time frame: Baseline, Day 7 and day 30
Change in Subjective Improvement in one month
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)
Time frame: Baseline , Day 7 and day 30
Change in Subjective Improvement in one month
Using Modified Vancouver Scar Scale (Evaluating pigmentation (score 0-3), vascularity (0-3), pliability (0-5), height (0-5))
Time frame: Baseline , Day 7 and day 30
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