Microneedling Therapy With or Without Amnion Bilayer Sheeting on Scar Tissue

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Scars, Hypertrophic, Burn Scar

Intervention / Treatment
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* Procedure: Microoneedling and Amnion Bilayer
* Procedure: Microoneedling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Microneedling and Amnion Bilayer<br>Microneedling is a dermaroller procedure that uses small needles to prick the skin. Amnion bilayer is used as an additional therapy after microneedling therapy. | Procedure: Microoneedling and Amnion Bilayer<br>* 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.<br>|
| Placebo Comparator: Microneedling<br>Microneedling is a dermaroller procedure that uses small needles to prick the skin. | Procedure: Microoneedling<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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)) | Baseline , Day 7 and day 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microneedling, Amnion bilayer, Scar