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

The Hong Kong Polytechnic University8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Cicatrix, Hypertrophic Rehabilitation

Interventions

SSCPOTHER

Insert

SPMSOTHER

Pressure therapy

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subjects with Hypertrophic Scar(HS); 2. 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; 3. subjects age between 20 and 70 years, cooperative, and good compliance with treatment. Exclusion Criteria: 1. the HS area had an open wound or infection; 2. the HS had been treated with steroid injections or other intervention (such as traditional Chinese medicine or laser therapy) before the study; or 3. the patient had a medical condition that might affect wound healing (e.g., diabetes mellitus or another serious medical problem).

Outcomes

Primary Outcomes

Change of Scar Pliability measured by the DermaLab Combo

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

Time frame: baseline and 6 weeks

Secondary Outcomes

Change of Scar Thickness measured by the diagnostic ultrasound system

Scar thickness is measured by the diagnostic ultrasound system

Time frame: baseline and 6 weeks

Change of Scar Pigmentation measured by the DermaLab Combo

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.

Time frame: baseline and 6 weeks

Change of Scar Vascularity measured by the DermaLab Combo

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.

Time frame: baseline and 6 weeks

Occurrence of blistering

Occurence of blistering is observed and reported by research staff

Time frame: up to 6 weeks

Occurrence of skin breakdown

Occurence of skin breakdown is observed and reported by research staff

Time frame: up to 6 weeks

Occurrence of rash

Occurence of rash is observed and reported by research staff

Time frame: up to 6 weeks

Data from ClinicalTrials.gov

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