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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-30

Study Completion Date

2020-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cicatrix, Hypertrophic Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

The ultrasound data will be processed and the data will be analysed by analysts who are blinded.

Study Groups

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SSCP + SPMS

Group Type EXPERIMENTAL

compression

Intervention Type DEVICE

compression will be delivered using compression garment

occlusion

Intervention Type DEVICE

occlusion will be delivered using silicone gel sheeting

PG

Group Type ACTIVE_COMPARATOR

compression

Intervention Type DEVICE

compression will be delivered using compression garment

Interventions

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compression

compression will be delivered using compression garment

Intervention Type DEVICE

occlusion

occlusion will be delivered using silicone gel sheeting

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No