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

Effectiveness of a Combined Adequate Pressure and Silicone Intervention in Comparison With Conventional Pressure Therapy for Hypertrophic Scar Treatment: a Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Rehabilitation; Cicatrix, Hypertrophic
• Intervention / Treatment: Device: compression; Device: occlusion

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cecilia Li, PhD; Phone Number: 852-27666715; Email: cecilia.li@polyu.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SSCP + SPMS	Device: compression; compression will be delivered using compression garment; Device: occlusion; occlusion will be delivered using silicone gel sheeting
ACTIVE_COMPARATOR: PG	Device: compression; compression will be delivered using compression garment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Investigators: Principal Investigator: Cecilia Li, PhD, The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2018
• Primary Completion (ANTICIPATED): July 1, 2020
• Study Completion (ANTICIPATED): July 1, 2020

Study Registration Dates

• First Submitted: May 23, 2018
• First Submitted That Met QC Criteria: August 9, 2018
• First Posted (ACTUAL): August 14, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 14, 2018
• Last Update Submitted That Met QC Criteria: August 9, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: silicone gel; insert; pressure therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Anatomical; Fibrosis; Hypertrophy; Cicatrix; Cicatrix, Hypertrophic
• Other Study ID Numbers: HSEARS20160418002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No