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

• ClinicalTrials.gov Identifier: NCT03469830
• Recruitment Status: Completed
• First Posted: March 19, 2018
• Last Update Posted: March 29, 2018
• Sponsor: The Hong Kong Polytechnic University
• Information provided by (Responsible Party): The Hong Kong Polytechnic University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cicatrix, Hypertrophic; Rehabilitation	Other: SSCP; Other: SPMS	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Masking Description: The subjects and the analyser of the data were blinded.
• Primary Purpose: Treatment
• Official Title: The Effectiveness of a Smart Scar Care Pad and Pressure Therapy Versus Pressure Therapy in Hypertrophic Scar Management: a Pilot Study
• Actual Study Start Date: November 1, 2015
• Actual Primary Completion Date: November 1, 2016
• Actual Study Completion Date: November 1, 2016

Arms and Interventions

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 Name: The Smart Scar Care PAd; Other: SPMS; Pressure therapy; Other Name: 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 Name: The Smart Pressure Monitored Suit

Outcome Measures

Primary Outcome Measures :

1. Change of Scar Pliability measured by the DermaLab Combo [ Time Frame: baseline and 6 weeks ]
   Scar pliability is represented by the Young's modulus measured by the elasticity measurement of the DermaLab Combo

Secondary Outcome Measures :

1. Change of Scar Thickness measured by the diagnostic ultrasound system [ Time Frame: baseline and 6 weeks ]
   Scar thickness is measured by the diagnostic ultrasound system
2. Change of Scar Pigmentation measured by the DermaLab Combo [ Time Frame: baseline and 6 weeks ]
   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.
3. Change of Scar Vascularity measured by the DermaLab Combo [ Time Frame: baseline and 6 weeks ]
   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.
4. Occurrence of blistering [ Time Frame: up to 6 weeks ]
   Occurence of blistering is observed and reported by research staff
5. Occurrence of skin breakdown [ Time Frame: up to 6 weeks ]
   Occurence of skin breakdown is observed and reported by research staff
6. Occurrence of rash [ Time Frame: up to 6 weeks ]
   Occurence of rash is observed and reported by research staff

Eligibility Criteria

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

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).

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: The Hong Kong Polytechnic University
• ClinicalTrials.gov Identifier: NCT03469830
• Other Study ID Numbers: HSEARS20140618002-01
• First Posted: March 19, 2018
• Last Update Posted: March 29, 2018
• Last Verified: March 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by The Hong Kong Polytechnic University:

insert; pressure therapy; silicone gel

Additional relevant MeSH terms:

Hypertrophy; Cicatrix, Hypertrophic; Cicatrix; Pathological Conditions, Anatomical; Fibrosis; Pathologic Processes