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

The Hong Kong Polytechnic University

Status: Completed

Conditions: Rehabilitation; Cicatrix, Hypertrophic

Treatments: Other: SSCP; Other: SPMS

Study type: Interventional

Funder types: Other

Identifiers

NCT03469830

HSEARS20140618002-01

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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8 participants in 2 patient groups

SSCP & SPMS

Experimental group

Description:

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.

Treatment:

Other: SPMS

Other: SSCP

SPMS

Active Comparator group

Description:

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.

Treatment:

Other: SPMS