Trials / Unknown
UnknownNCT04995302
Microneedling Therapy With or Without Amnion Bilayer Sheeting on Scar Tissue
The Comparison of Microneedling Therapy With or Without Amnion Bilayer Sheeting on Post-Burn Hypertrophic Scar Tissue
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 17 (estimated)
- Sponsor
- Dr.dr.Irma Bernadette, SpKK (K) · Academic / Other
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Microoneedling 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. |
| PROCEDURE | Microoneedling | 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. |
Timeline
- Start date
- 2021-09-01
- Primary completion
- 2021-12-30
- Completion
- 2022-01-31
- First posted
- 2021-08-06
- Last updated
- 2021-08-06
Locations
1 site across 1 country: Indonesia
Source: ClinicalTrials.gov record NCT04995302. Inclusion in this directory is not an endorsement.