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

Not Applicable

• Conditions: Rehabilitation; Cicatrix, Hypertrophic
• Interventions: Device: compression; Device: occlusion

• Registration Number: NCT03628495
• Lead Sponsor: The Hong Kong Polytechnic University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-23
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-09
• Last Update Submitted: 2018-08-09
• Study First Posted: 2018-08-14
• Last Update Posted: 2018-08-14
• Study Start: 2018-09
• Primary Completion: 2020-07
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SSCP + SPMS	occlusion	-
SSCP + SPMS	compression	-
PG	compression	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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.