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

Rehabilitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03469830
• Other study ID #: HSEARS20140618002-01
• Status: Completed
• Phase: N/A
• First received: March 13, 2018
• Last updated: March 27, 2018
• Start date: November 1, 2015
• Est. completion date: November 1, 2016

Study information

• Verified date: March 2018
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: November 1, 2016
• Est. primary completion date: November 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cicatrix
• Cicatrix, Hypertrophic
• Hypertrophy
• Rehabilitation

Intervention

Other:
• SSCP
Insert
• SPMS
Pressure therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	baseline and 6 weeks
Secondary	Change of Scar Thickness measured by the diagnostic ultrasound system	Scar thickness is measured by the diagnostic ultrasound system	baseline and 6 weeks
Secondary	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.	baseline and 6 weeks
Secondary	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.	baseline and 6 weeks
Secondary	Occurrence of blistering	Occurence of blistering is observed and reported by research staff	up to 6 weeks
Secondary	Occurrence of skin breakdown	Occurence of skin breakdown is observed and reported by research staff	up to 6 weeks
Secondary	Occurrence of rash	Occurence of rash is observed and reported by research staff	up to 6 weeks