Clinical trial NCT04995302: Microneedling Therapy With or Without Amnion Bilayer Sheeting on Scar Tissue
Official title: The Comparison of Microneedling Therapy With or Without Amnion Bilayer Sheeting on Post-Burn Hypertrophic Scar Tissue
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Scars, Hypertrophic
Burn Scar
Keywords: Microneedling
Amnion bilayer
Scar
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2021-08-06
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Subjective Pain in one month
timeFrame: Baseline, day 7, day 30
measure: Change in Erythema Degree in one month
timeFrame: Baseline, day 7, day 30
measure: Change in Dermoscopy Evaluation in one month
timeFrame: Baseline, day 7 , day 30
measure: Change in Biopsy Evaluation in one month
timeFrame: Baseline, Day 7 and day 30
measure: Change in Skin Thickness in one month
timeFrame: Baseline, Day 7 and day 30
measure: Change in Subjective Improvement in one month
timeFrame: Baseline , Day 7 and day 30
measure: Change in Subjective Improvement in one month
timeFrame: Baseline , Day 7 and day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: dr. Cipto Mangunkusumo Hospital
state: Jakarta Pusat
Study officials:
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Irma B Sitohang
role: PRINCIPAL_INVESTIGATOR
References: