The Vascularity Changes of Scars With Laser Therapy
1 other identifier
interventional
45
2 countries
2
Brief Summary
The purpose of this study is to explore the effects of pulsed dye laser on managing scar vascularity and thickness.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2019
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2019
CompletedStudy Start
First participant enrolled
May 31, 2019
CompletedFirst Posted
Study publicly available on registry
June 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 27, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 27, 2020
CompletedMarch 10, 2020
May 1, 2019
9 months
May 24, 2019
March 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
scar erythema
Dermoscopy captures the scar photo and measures degrees of scar erythema.
3 months
scar blood flow
Ultrasound measures blood flow in scar tissues
3 months
scar thickness
Ultrasound measures scar thickness.
3 months
Secondary Outcomes (1)
patient and observer scar assessment scale (POSAS)
3 months
Study Arms (2)
Laser group
EXPERIMENTALParticipants in this group receive pulsed dye laser to treat the scar.
Control group
ACTIVE COMPARATORParticipants in this group receive standardized care.
Interventions
The scar will receive PDL 585 nm using a 7 mm spot size. First treatment will be within 1 year post injury.
the scar will receive standardized care such as scar massage.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Hong Kong Polytechnic Universitylead
- Chinese University of Hong Kongcollaborator
- Southwest Hospital, Chinacollaborator
Study Sites (2)
Southwest Hospital
Chongqing, China
Prince of Wales Hospital
Hong Kong, Hong Kong
Related 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.
PMID: 30545695BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cecilia Li-tsang
The Hong Kong Polytechnic University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2019
First Posted
June 14, 2019
Study Start
May 31, 2019
Primary Completion
February 27, 2020
Study Completion
February 27, 2020
Last Updated
March 10, 2020
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share