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

Rehabilitation Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03628495
• Other study ID #: HSEARS20160418002
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2018
• Est. completion date: July 2020

Study information

• Verified date: August 2018
• Source: The Hong Kong Polytechnic University
• Contact: Cecilia Li, PhD
• Phone: 852-27666715
• Email: cecilia.li[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cicatrix
• Cicatrix, Hypertrophic
• Hypertrophy
• Rehabilitation

Intervention

Device:
• compression
compression will be delivered using compression garment
• occlusion
occlusion will be delivered using silicone gel sheeting

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Itchiness	HS Itchiness measured by the Numerical rating scale	at baseline, one and six month after treatment
Secondary	QoL	SF-36 will be used to measure the Quality of Life.	at baseline, one and six month after treatment