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

NCT03628495 | Unknown

• 1 other identifier: HSEARS20160418002
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cicatrix, Hypertrophic; Rehabilitation

Keywords

insert; pressure therapy; silicone gel

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change from baseline HS color at 6 months

  at baseline, one and six month after treatment

• Change from baseline HS pliability at 6 months

  at baseline, one and six month after treatment

• Change from baseline HS hydration at 6 months

  at baseline, one and six month after treatment

• Itchiness

  at baseline, one and six month after treatment

• QoL

  at baseline, one and six month after treatment

Study Arms (2)

SSCP + SPMS

EXPERIMENTAL

Device: compression; Device: occlusion

PG

ACTIVE COMPARATOR

Device: compression

Interventions

compression DEVICE

compression will be delivered using compression garment

PG; SSCP + SPMS

occlusion DEVICE

occlusion will be delivered using silicone gel sheeting

SSCP + SPMS

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

MeSH Terms

Conditions

Cicatrix, Hypertrophic

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Cecilia Li, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cecilia Li, PhD

CONTACT

852-27666715; cecilia.li@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The ultrasound data will be processed and the data will be analysed by analysts who are blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: August 14, 2018
• Study Start: September 1, 2018
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: August 14, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share