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Completed

NCT Number: NCT03986346

The Vascularity Changes of Scars With Laser Therapy

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

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Key information

Conditions

Hypertrophic Scar Cicatrix Cicatrix, Hypertrophic Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

16 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Southwest Hospital, Chongqing, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pulsed dye laser

Device

The scar will receive PDL 585 nm using a 7 mm spot size. First treatment will be within 1 year post injury.

standardized care

Other

the scar will receive standardized care such as scar massage.

Primary outcomes

  1. scar erythema

    Time frame: 3 months

    Dermoscopy captures the scar photo and measures degrees of scar erythema.

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • Chinese University of Hong Kong
  • Southwest Hospital, China

Registry information

Official study title

The Vascularity Changes of Scars With Receiving Pulsed Dye Laser

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 14, 2019
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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