Effectiveness of a Combined Pressure and Silicone Intervention for Hypertrophic Scar Treatment

Study Overview
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Brief Summary
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Pressure therapy (PT) and silicone therapy are recommended as first-line non-invasive treatments HS, yet the effectiveness of the combination of these two treatments through an RCT trial has not been established yet. This study aims to examine the effectiveness of the combination of adequate pressure therapy and silicone gel sheeting implemented by Smart Scar Care Pad (SSCP) + Smart Pressure Monitored Suit (SPMS) versus conventional Pressure Garment (PG in the management of severe HS in adult. It is hypothesized that the combination of adequate pressure therapy and silicone gel sheeting will demonstrate its superiority in improving scar parameters than conventional pressure garment therapy.

Official Title
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Effectiveness of a Combined Adequate Pressure and Silicone Intervention in Comparison With Conventional Pressure Therapy for Hypertrophic Scar Treatment: a Randomized Controlled Trial

Conditions
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Cicatrix, Hypertrophic, Rehabilitation

Intervention / Treatment
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* Device: compression
* Device: occlusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The Vancouver Scar Scale (VSS) will be used to screen candidates for the study.10 Isolated scars with a total score of 4 or higher and the score of each item equal to or greater than 1 will be included. The scar size should also reach 2*2 cm2 or above to allow adequate area for assessment tool attachement. Consenting adult's age between 19 to 60 years old who is able to provide written consent, cooperative, and good compliance with treatment. Exclusion Criteria: the HS area have an open wound or infection; the HS have been treated with steroid injections or other intervention (such as traditional Chinese medicine or laser therapy) prior to the study; the patients have a medical condition that might affect wound healing (e.g., diabetes mellitus or another serious medical problem); the patients with comorbidities that might affect their compliance to treatment: such as severe scar contracture at adjacent area that might be scheduled for reconstructive surgery.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SSCP + SPMS<br> | Device: compression<br>* compression will be delivered using compression garment<br>Device: occlusion<br>* occlusion will be delivered using silicone gel sheeting<br>|
| Active Comparator: PG<br> | Device: compression<br>* compression will be delivered using compression garment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline HS thickness at 6 months | HS thickness measured by the Diagnostic Ultrasound System | at baseline, one and six month after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline HS color at 6 months | HS color measured by the DermaLab Combo Color measurement | at baseline, one and six month after treatment | 
| Change from baseline HS pliability at 6 months | HS pliability measured by the DermaLab Combo elasticity measurement | at baseline, one and six month after treatment | 
| Change from baseline HS hydration at 6 months | HS hydration measured by the DermaLab Combo hydration measurement | at baseline, one and six month after treatment | 
| Itchiness | HS Itchiness measured by the Numerical rating scale | at baseline, one and six month after treatment | 
| QoL | SF-36 will be used to measure the Quality of Life. | at baseline, one and six month after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insert, pressure therapy, silicone gel