Burn Scar, Scars, Hypertrophic
Conditions
Keywords
Microneedling, Amnion bilayer, Scar
Brief summary
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
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.
Interventions
PROCEDUREMicrooneedling and Amnion Bilayer
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.
PROCEDUREMicrooneedling
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.
Sponsors
Dr.dr.Irma Bernadette, SpKK (K)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Subjective Pain in one month | Baseline, day 7, day 30 | Using Visual Analog Scale (0-10, 0 indicates no pain and 10 indicates severe pain) |
| Change in Erythema Degree in one month | 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 | Baseline, day 7 , day 30 | Qualitative description of blood vessel structure, pigmentation density and erythema |
| Change in Biopsy Evaluation in one month | Baseline, Day 7 and day 30 | Descriptive evaluation using HE staining |
| Change in Skin Thickness in one month | Baseline, Day 7 and day 30 | Evaluation with USG of epidermal and dermal layer (in pixels) |
| Change in Subjective Improvement in one month | 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) |
Countries
Indonesia
Contacts
Primary ContactIrma B Sitohang
Outcome results
None listed