The Vascularity Changes of Scars With Laser Therapy

Hypertrophic Scar Clinical Trial

Official title:

The Vascularity Changes of Scars With Receiving Pulsed Dye Laser

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03986346
• Other study ID #: HSEARS20190402002
• Status: Completed
• Phase: N/A
• Start date: May 31, 2019
• Est. completion date: February 27, 2020

Study information

• Verified date: May 2019
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to explore the effects of pulsed dye laser on managing scar vascularity and thickness.

Description:

The pulsed dye laser is increasingly used in clinical settings to manage scars and shows promising outcomes.The pulsed dye laser targets at micro-vascular structures in scar tissues. This study aims to explore the vascularity changes in scars with pulsed dye laser during the scar formation process.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 27, 2020
• Est. primary completion date: February 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

Inclusion Criteria:

• scars caused by burn injury or related trauma;

• wound healing days over 3 weeks;

• days post injury less than 1 year;

• ability and willingness to comply with all the treatment and assessment procedures.

Exclusion Criteria:

• history of steroid injection or graft surgery;

• history of keloid scarring;

• open wound or active infection;

• conditions that affect wound healing, such as diabetes mellitus.

Related Conditions & MeSH terms

• Cicatrix, Hypertrophic
• Hypertrophic Scar
• Hypertrophy

Intervention

Device:
• pulsed dye laser
The scar will receive PDL 585 nm using a 7 mm spot size. First treatment will be within 1 year post injury.

Other:
• standardized care
the scar will receive standardized care such as scar massage.

Locations

Country	Name	City	State
China	Southwest Hospital	Chongqing
Hong Kong	Prince of Wales Hospital	Hong Kong

Sponsors (3)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	Chinese University of Hong Kong, Southwest Hospital, China

Countries where clinical trial is conducted

China,  Hong Kong, 

References & Publications (1)

Deng H, Li-Tsang CWP. Measurement of vascularity in the scar: A systematic review. Burns. 2019 Sep;45(6):1253-1265. doi: 10.1016/j.burns.2018.10.026. Epub 2018 Dec 10. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	scar erythema	Dermoscopy captures the scar photo and measures degrees of scar erythema.	3 months
Primary	scar blood flow	Ultrasound measures blood flow in scar tissues	3 months
Primary	scar thickness	Ultrasound measures scar thickness.	3 months
Secondary	patient and observer scar assessment scale (POSAS)	The POSAS measures scar vascularity, pigmentation, pigmentation, thickness, relief, pliability and surface area. Every parameter ranges from 1 to 10, and higher score indicates worse scar performance in that parameter. The total score of POSAS is calculated by summing all the parameters' scores.	3 months