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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03469830
Enrollment
8
Registered
2018-03-19
Start date
2015-11-01
Completion date
2016-11-01
Last updated
2018-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cicatrix, Hypertrophic, Rehabilitation

Keywords

insert, pressure therapy, silicone gel

Brief summary

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.

Interventions

OTHERSSCP

Insert

OTHERSPMS

Pressure therapy

Sponsors

The Hong Kong Polytechnic University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

The subjects and the analyser of the data were blinded.

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Change of Scar Pliability measured by the DermaLab Combobaseline and 6 weeksScar pliability is represented by the Young's modulus measured by the elasticity measurement of the DermaLab Combo

Secondary

MeasureTime frameDescription
Change of Scar Pigmentation measured by the DermaLab Combobaseline and 6 weeksScar 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.
Change of Scar Vascularity measured by the DermaLab Combobaseline and 6 weeksScar 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.
Change of Scar Thickness measured by the diagnostic ultrasound systembaseline and 6 weeksScar thickness is measured by the diagnostic ultrasound system
Occurrence of skin breakdownup to 6 weeksOccurence of skin breakdown is observed and reported by research staff
Occurrence of rashup to 6 weeksOccurence of rash is observed and reported by research staff
Occurrence of blisteringup to 6 weeksOccurence of blistering is observed and reported by research staff

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026