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

NCT03469830 | Completed

• 1 other identifier: HSEARS20140618002-01
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

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

Keywords

insert; pressure therapy; silicone gel

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change of Scar Thickness measured by the diagnostic ultrasound system

  baseline and 6 weeks

• Change of Scar Pigmentation measured by the DermaLab Combo

  baseline and 6 weeks

• Change of Scar Vascularity measured by the DermaLab Combo

  baseline and 6 weeks

• Occurrence of blistering

  up to 6 weeks

• Occurrence of skin breakdown

  up to 6 weeks

Study Arms (2)

SSCP & SPMS

EXPERIMENTAL

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; Other: SPMS

SPMS

ACTIVE COMPARATOR

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

Interventions

SSCP OTHER

Insert

Also known as: The Smart Scar Care PAd

SSCP & SPMS

SPMS OTHER

Pressure therapy

Also known as: The Smart Pressure Monitored Suit

SPMS; SSCP & SPMS

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with Hypertrophic Scar(HS);
• 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;
• subjects age between 20 and 70 years, cooperative, and good compliance with treatment.

You may not qualify if:

• the HS area had an open wound or infection;
• the HS had been treated with steroid injections or other intervention (such as traditional Chinese medicine or laser therapy) before the study; or
• the patient had a medical condition that might affect wound healing (e.g., diabetes mellitus or another serious medical problem).

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

MeSH Terms

Conditions

Cicatrix, Hypertrophic

Interventions

Polymorphism, Single-Stranded Conformational

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polymorphism, Genetic; Genetic Variation; Genetic Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The subjects and the analyser of the data were blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: March 19, 2018
• Study Start: November 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: March 29, 2018

Record last verified: 2018-03