Microneedling Therapy With or Without Amnion Bilayer Sheeting on Scar Tissue

Burn Scar Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04995302
• Other study ID #: MicroneedlingScar
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: July 2021
• Source: Indonesia University
• Contact: Irma B Sitohang
• Phone: +62818130761
• Email: irma_bernadette[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 17
• Est. completion date: January 31, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Burn Scar
• Cicatrix
• Cicatrix, Hypertrophic
• Hypertrophy
• Scars, Hypertrophic

Intervention

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.
• 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.

Locations

Country	Name	City	State
Indonesia	dr. Cipto Mangunkusumo Hospital	Jakarta	Jakarta Pusat

Sponsors (1)

Lead Sponsor	Collaborator
Dr.dr.Irma Bernadette, SpKK (K)

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Change in Dermoscopy Evaluation in one month	Qualitative description of blood vessel structure, pigmentation density and erythema	Baseline, day 7 , day 30
Primary	Change in Biopsy Evaluation in one month	Descriptive evaluation using HE staining	Baseline, Day 7 and day 30
Primary	Change in Skin Thickness in one month	Evaluation with USG of epidermal and dermal layer (in pixels)	Baseline, Day 7 and day 30
Primary	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
Primary	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