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The Vascular Changes of Scars With Laser Therapy

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ClinicalTrials.gov Identifier: NCT03986346
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : July 10, 2019
Sponsor:
Collaborator:
Chinese University of Hong Kong
Information provided by (Responsible Party):
The Hong Kong Polytechnic University

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

Condition or disease Intervention/treatment Phase
Scar Device: pulsed dye laser Other: pressure therapy Not Applicable

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 vascular structures in scar tissue. This study aims to explore the vascular changes throughout the scar formation process with receiving the pulsed dye laser.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Participants who receive pulsed dye laser and participants who receive pressure therapy will be recruited from 2 different hospitals separately.
Primary Purpose: Treatment
Official Title: The Vascular Changes of Scars With Receiving Pulsed Dye Laser
Actual Study Start Date : June 21, 2019
Estimated Primary Completion Date : February 29, 2020
Estimated Study Completion Date : February 29, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arm Intervention/treatment
Experimental: Laser group
Participants in this group receive pulsed dye laser to treat the scar.
Device: pulsed dye laser
The scar will receive PDL 595 nm using a 7 mm spot size. First treatment will be within 1 year post injury.

Active Comparator: Pressure therapy group
Participants in this group receive pressure therapy to treat the scar.
Other: pressure therapy
Pressure garment will be prescribed for participants to manage scars.




Primary Outcome Measures :
  1. scar redness [ Time Frame: 3 months ]
    Dermoscopy captures the scar photo and measures degrees of scar redness.

  2. scar blood flow [ Time Frame: 3 months ]
    Ultrasound measures blood flow in scar tissues

  3. scar thickness [ Time Frame: 3 months ]
    Ultrasound measures scar thickness.


Secondary Outcome Measures :
  1. patient and observer scar assessment scale (POSAS) [ Time Frame: 3 months ]
    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.



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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986346


Contacts
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Contact: Huan DENG 68747553 huan.rs.deng@connect.polyu.hk

Locations
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Hong Kong
Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong
Contact: Teresa Tan         
Sponsors and Collaborators
The Hong Kong Polytechnic University
Chinese University of Hong Kong
Investigators
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Principal Investigator: Cecilia Li-tsang The Hong Kong Polytechnic University

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Responsible Party: The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT03986346     History of Changes
Other Study ID Numbers: HSEARS20190402002
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by The Hong Kong Polytechnic University:
scar
pulsed dye laser

Additional relevant MeSH terms:
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Cicatrix
Fibrosis
Pathologic Processes