The Comparison of Microneedling Therapy With or Without Amnion Bilayer Sheeting on Post-Burn Hypertrophic Scar Tissue
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Change in Biopsy Evaluation in one month
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients with scars less than 5 cm in diameter
- •Patients with scars localized solely in the face
- •Hypertrophic scars with keloid
- •Patients with comorbidities
研究组 & 干预措施
Microneedling and Amnion Bilayer
Microneedling is a dermaroller procedure that uses small needles to prick the skin. Amnion bilayer is used as an additional therapy after microneedling therapy.
干预措施: Microoneedling and Amnion Bilayer (Procedure)
Microneedling
Microneedling is a dermaroller procedure that uses small needles to prick the skin.
干预措施: Microoneedling (Procedure)
结局指标
主要结局
Change in Biopsy Evaluation in one month
时间窗: Baseline, Day 7 and day 30
Descriptive evaluation using HE staining
Change in Subjective Improvement in one month
时间窗: Baseline , Day 7 and day 30
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)
Change in Subjective Pain in one month
时间窗: Baseline, day 7, day 30
Using Visual Analog Scale (0-10, 0 indicates no pain and 10 indicates severe pain)
Change in Skin Thickness in one month
时间窗: Baseline, Day 7 and day 30
Evaluation with USG of epidermal and dermal layer (in pixels)
Change in Erythema Degree in one month
时间窗: Baseline, day 7, day 30
Using Erythema score (0-4, 0 indicates no erythema and 4 indicates severe erythema)
Change in Dermoscopy Evaluation in one month
时间窗: Baseline, day 7 , day 30
Qualitative description of blood vessel structure, pigmentation density and erythema
次要结局
未报告次要终点
研究者
Dr.dr.Irma Bernadette, SpKK (K)
Irma Bernadette S. Sitohang, MD, PhD - Head of Cosmetic Dermatology Division, Department of Dermatology and Venereology, Faculty of Medicine, Universitas Indonesia, dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia
Indonesia University