Clinical trial NCT03628495: Effectiveness of a Combined Pressure and Silicone Intervention for Hypertrophic Scar Treatment
Official title: Effectiveness of a Combined Adequate Pressure and Silicone Intervention in Comparison With Conventional Pressure Therapy for Hypertrophic Scar Treatment: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cicatrix, Hypertrophic
Rehabilitation
Keywords: insert
pressure therapy
silicone gel
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline HS thickness at 6 months
timeFrame: at baseline, one and six month after treatment
Secondary outcomes:
measure: Change from baseline HS color at 6 months
timeFrame: at baseline, one and six month after treatment
measure: Change from baseline HS pliability at 6 months
timeFrame: at baseline, one and six month after treatment
measure: Change from baseline HS hydration at 6 months
timeFrame: at baseline, one and six month after treatment
measure: Itchiness
timeFrame: at baseline, one and six month after treatment
measure: QoL
timeFrame: at baseline, one and six month after treatment
Other outcomes:
Locations:
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Cecilia Li, PhD
role: PRINCIPAL_INVESTIGATOR
References: