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

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 Overview

• Status: Completed
• Conditions: Rehabilitation; Cicatrix, Hypertrophic
• Intervention / Treatment: Other: SSCP; Other: SPMS

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SSCP & SPMS; The smart scar care pad (SCCP): The SCCP is a newly invented insert material that can maximise treatment outcomes via enhanced compression and occlusion. The wearing regime for SCCP is 4 hours a day for the first day, with 2-hour increments added every other day until the total wearing time reached 23 hours. SSCP was cleaned twice a day for hygienic reasons. The smart pressure monitored suit(SPMS): The SPMS is a type of custom-made pressure garment. SPMS was used 23 hours a day and only removed when showering.	Other: SSCP; Insert; Other Names: The Smart Scar Care PAd; Other: SPMS; Pressure therapy; Other Names: The Smart Pressure Monitored Suit
Active Comparator: SPMS; The smart pressure monitored suit(SPMS): The SPMS is a type of custom-made pressure garment. SPMS was used 23 hours a day and only removed when showering.	Other: SPMS; Pressure therapy; Other Names: The Smart Pressure Monitored Suit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: March 13, 2018
• First Submitted That Met QC Criteria: March 13, 2018
• First Posted (Actual): March 19, 2018

Study Record Updates

• Last Update Posted (Actual): March 29, 2018
• Last Update Submitted That Met QC Criteria: March 27, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: silicone gel; insert; pressure therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Anatomical; Fibrosis; Hypertrophy; Cicatrix; Cicatrix, Hypertrophic
• Other Study ID Numbers: HSEARS20140618002-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No