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The Vascularity Changes of Scars With Laser Therapy

Primary Purpose

Hypertrophic Scar

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
pulsed dye laser
standardized care
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertrophic Scar focused on measuring hypertrophic scar, pulsed dye laser

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Southwest Hospital
  • Prince of Wales Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laser group

Control group

Arm Description

Participants in this group receive pulsed dye laser to treat the scar.

Participants in this group receive standardized care.

Outcomes

Primary Outcome Measures

scar erythema
Dermoscopy captures the scar photo and measures degrees of scar erythema.
scar blood flow
Ultrasound measures blood flow in scar tissues
scar thickness
Ultrasound measures scar thickness.

Secondary Outcome Measures

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.

Full Information

First Posted
May 24, 2019
Last Updated
March 6, 2020
Sponsor
The Hong Kong Polytechnic University
Collaborators
Chinese University of Hong Kong, Southwest Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT03986346
Brief Title
The Vascularity Changes of Scars With Laser Therapy
Official Title
The Vascularity Changes of Scars With Receiving Pulsed Dye Laser
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
May 31, 2019 (Actual)
Primary Completion Date
February 27, 2020 (Actual)
Study Completion Date
February 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
Chinese University of Hong Kong, Southwest Hospital, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Scar
Keywords
hypertrophic scar, pulsed dye laser

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser group
Arm Type
Experimental
Arm Description
Participants in this group receive pulsed dye laser to treat the scar.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Participants in this group receive standardized care.
Intervention Type
Device
Intervention Name(s)
pulsed dye laser
Intervention Description
The scar will receive PDL 585 nm using a 7 mm spot size. First treatment will be within 1 year post injury.
Intervention Type
Other
Intervention Name(s)
standardized care
Intervention Description
the scar will receive standardized care such as scar massage.
Primary Outcome Measure Information:
Title
scar erythema
Description
Dermoscopy captures the scar photo and measures degrees of scar erythema.
Time Frame
3 months
Title
scar blood flow
Description
Ultrasound measures blood flow in scar tissues
Time Frame
3 months
Title
scar thickness
Description
Ultrasound measures scar thickness.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
patient and observer scar assessment scale (POSAS)
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cecilia Li-tsang
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southwest Hospital
City
Chongqing
Country
China
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30545695
Citation
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.
Results Reference
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The Vascularity Changes of Scars With Laser Therapy

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