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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microneedling and Amnion Bilayer | Active Comparator | Microneedling is a dermaroller procedure that uses small needles to prick the skin. Amnion bilayer is used as an additional therapy after microneedling therapy. |
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| Microneedling | Placebo Comparator | Microneedling is a dermaroller procedure that uses small needles to prick the skin. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microoneedling and Amnion Bilayer | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Subjective Pain in one month | Using Visual Analog Scale (0-10, 0 indicates no pain and 10 indicates severe pain) | 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) | Baseline, day 7, day 30 |
| Change in Dermoscopy Evaluation in one month | Qualitative description of blood vessel structure, pigmentation density and erythema | Baseline, day 7 , day 30 |
| Change in Biopsy Evaluation in one month | Descriptive evaluation using HE staining | Baseline, Day 7 and day 30 |
| Change in Skin Thickness in one month | Evaluation with USG of epidermal and dermal layer (in pixels) | 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) | 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)) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Irma B Sitohang | Contact | +62818130761 | irma_bernadette@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Irma B Sitohang | Fakultas Kedokteran Universitas Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| dr. Cipto Mangunkusumo Hospital | Jakarta | Jakarta Pusat | 10430 | Indonesia |
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| ID | Term |
|---|---|
| D017439 | Cicatrix, Hypertrophic |
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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
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| Microoneedling | Procedure | 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. |
|
| Baseline , Day 7 and day 30 |