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Completed

NCT Number: NCT03469830

The Development and Application of "Scar-care" Padding on Management of Hypertrophic Scar

This study explores the smart scar care pad's potential therapeutic effect in treatment hypertrophic scar while elucidating the adverse effects if there is any. Half of the participant receives traditional treatment of pressure garment and the other half receives the smart scar care pad together with pressure garment.

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Key information

Conditions

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

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects with Hypertrophic Scar(HS);
  • the HS had a total Vancouver Scar Scale (VSS) score of 4 or higher and the score of each item equal to or greater than 1;
  • subjects age between 20 and 70 years, cooperative, and good compliance with treatment.

Exclusion criteria

  • the HS area had an open wound or infection;
  • the HS had been treated with steroid injections or other intervention (such as traditional Chinese medicine or laser therapy) before the study; or
  • the patient had a medical condition that might affect wound healing (e.g., diabetes mellitus or another serious medical problem).

Treatment and study plan

SSCP

Other

Insert

Other names: The Smart Scar Care PAd

SPMS

Other

Pressure therapy

Other names: The Smart Pressure Monitored Suit

Primary outcomes

  1. Change of Scar Pliability measured by the DermaLab Combo

    Time frame: baseline and 6 weeks

    Scar pliability is represented by the Young's modulus measured by the elasticity measurement of the DermaLab Combo

Secondary outcomes

  1. Change of Scar Thickness measured by the diagnostic ultrasound system

    Time frame: baseline and 6 weeks

    Scar thickness is measured by the diagnostic ultrasound system

  2. Change of Scar Pigmentation measured by the DermaLab Combo

    Time frame: baseline and 6 weeks

    Scar pigmentation is represented by the melanin score generated by the color probe of the DermaLab Combo. The range of the score is 0-100, where a higher score indicates a higher melanin content.

  3. Change of Scar Vascularity measured by the DermaLab Combo

    Time frame: baseline and 6 weeks

    Scar vascularity is represented by the erythema score measured by the color probe of the DermaLab Combo. The range of the score is 0-100, where a higher score indicates a more erythematic situation.

  4. Occurrence of blistering

    Time frame: up to 6 weeks

    Occurence of blistering is observed and reported by research staff

  5. Occurrence of skin breakdown

    Time frame: up to 6 weeks

    Occurence of skin breakdown is observed and reported by research staff

  6. Occurrence of rash

    Time frame: up to 6 weeks

    Occurence of rash is observed and reported by research staff

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

The Effectiveness of a Smart Scar Care Pad and Pressure Therapy Versus Pressure Therapy in Hypertrophic Scar Management: a Pilot Study

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 19, 2018
Registry last updated
Mar 29, 2018

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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