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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SSCP + SPMS | Experimental |
| |
| PG | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| compression | Device | compression will be delivered using compression garment |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cecilia Li, PhD | Contact | 852-27666715 | cecilia.li@polyu.edu.hk |
| Name | Affiliation | Role |
|---|---|---|
| Cecilia Li, PhD | The Hong Kong Polytechnic University | Principal Investigator |
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| ID | Term |
|---|---|
| D017439 | Cicatrix, Hypertrophic |
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003766 | Dental Occlusion |
| ID | Term |
|---|---|
| D003813 | Dentistry |
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
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The ultrasound data will be processed and the data will be analysed by analysts who are blinded.
| occlusion | Device | occlusion will be delivered using silicone gel sheeting |
|
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 |