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

Primary Purpose

Cicatrix, Hypertrophic, Rehabilitation

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
compression
occlusion
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cicatrix, Hypertrophic focused on measuring insert, pressure therapy, silicone gel

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    SSCP + SPMS

    PG

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change from baseline HS thickness at 6 months
    HS thickness measured by the Diagnostic Ultrasound System

    Secondary Outcome Measures

    Change from baseline HS color at 6 months
    HS color measured by the DermaLab Combo Color measurement
    Change from baseline HS pliability at 6 months
    HS pliability measured by the DermaLab Combo elasticity measurement
    Change from baseline HS hydration at 6 months
    HS hydration measured by the DermaLab Combo hydration measurement
    Itchiness
    HS Itchiness measured by the Numerical rating scale
    QoL
    SF-36 will be used to measure the Quality of Life.

    Full Information

    First Posted
    May 23, 2018
    Last Updated
    August 9, 2018
    Sponsor
    The Hong Kong Polytechnic University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03628495
    Brief Title
    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

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2018 (Anticipated)
    Primary Completion Date
    July 2020 (Anticipated)
    Study Completion Date
    July 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The Hong Kong Polytechnic University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cicatrix, Hypertrophic, Rehabilitation
    Keywords
    insert, pressure therapy, silicone gel

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    The ultrasound data will be processed and the data will be analysed by analysts who are blinded.
    Allocation
    Randomized
    Enrollment
    72 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    SSCP + SPMS
    Arm Type
    Experimental
    Arm Title
    PG
    Arm Type
    Active Comparator
    Intervention Type
    Device
    Intervention Name(s)
    compression
    Intervention Description
    compression will be delivered using compression garment
    Intervention Type
    Device
    Intervention Name(s)
    occlusion
    Intervention Description
    occlusion will be delivered using silicone gel sheeting
    Primary Outcome Measure Information:
    Title
    Change from baseline HS thickness at 6 months
    Description
    HS thickness measured by the Diagnostic Ultrasound System
    Time Frame
    at baseline, one and six month after treatment
    Secondary Outcome Measure Information:
    Title
    Change from baseline HS color at 6 months
    Description
    HS color measured by the DermaLab Combo Color measurement
    Time Frame
    at baseline, one and six month after treatment
    Title
    Change from baseline HS pliability at 6 months
    Description
    HS pliability measured by the DermaLab Combo elasticity measurement
    Time Frame
    at baseline, one and six month after treatment
    Title
    Change from baseline HS hydration at 6 months
    Description
    HS hydration measured by the DermaLab Combo hydration measurement
    Time Frame
    at baseline, one and six month after treatment
    Title
    Itchiness
    Description
    HS Itchiness measured by the Numerical rating scale
    Time Frame
    at baseline, one and six month after treatment
    Title
    QoL
    Description
    SF-36 will be used to measure the Quality of Life.
    Time Frame
    at baseline, one and six month after treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Cecilia Li, PhD
    Phone
    852-27666715
    Email
    cecilia.li@polyu.edu.hk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Cecilia Li, PhD
    Organizational Affiliation
    The Hong Kong Polytechnic University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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