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

The Hong Kong Polytechnic University

Status

Unknown

Conditions

Rehabilitation

Cicatrix, Hypertrophic

Treatments

Device: compression

Device: occlusion

Study type

Interventional

Funder types

Other

Identifiers

NCT03628495

HSEARS20160418002

Details and patient eligibility

About

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.

Enrollment

72 estimated patients

Sex

All

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

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.