Cicatrix, Hypertrophic, Rehabilitation
Conditions
Keywords
insert, pressure therapy, silicone gel
Brief summary
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.
Interventions
DEVICEcompression
compression will be delivered using compression garment
DEVICEocclusion
occlusion will be delivered using silicone gel sheeting
Sponsors
The Hong Kong Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The ultrasound data will be processed and the data will be analysed by analysts who are blinded.
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline HS thickness at 6 months | at baseline, one and six month after treatment | HS thickness measured by the Diagnostic Ultrasound System |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline HS color at 6 months | at baseline, one and six month after treatment | HS color measured by the DermaLab Combo Color measurement |
| Change from baseline HS pliability at 6 months | at baseline, one and six month after treatment | HS pliability measured by the DermaLab Combo elasticity measurement |
| Change from baseline HS hydration at 6 months | at baseline, one and six month after treatment | HS hydration measured by the DermaLab Combo hydration measurement |
| Itchiness | at baseline, one and six month after treatment | HS Itchiness measured by the Numerical rating scale |
| QoL | at baseline, one and six month after treatment | SF-36 will be used to measure the Quality of Life. |
Contacts
Primary ContactCecilia Li, PhD
Outcome results
None listed