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

NCT ID: NCT03469830

Last Updated: 2018-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-01
• Study Completion Date: 2016-11-01

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.

Conditions

Cicatrix, Hypertrophic; Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

SSCP

Intervention Type: OTHER

Insert

SPMS

Intervention Type: OTHER

Pressure therapy

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.

Group Type: ACTIVE_COMPARATOR

SPMS

Intervention Type: OTHER

Pressure therapy

Interventions

SSCP

Insert

Intervention Type: OTHER

SPMS

Pressure therapy

Intervention Type: OTHER

Other Intervention Names

The Smart Scar Care PAd; The Smart Pressure Monitored Suit

Eligibility Criteria

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).

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

HSEARS20140618002-01

Identifier Type: -

Identifier Source: org_study_id