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
About this trial
This is an interventional treatment trial for Cicatrix, Hypertrophic focused on measuring insert, pressure therapy, silicone gel
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.
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
NCT ID
NCT03628495
First Posted
May 23, 2018
Last Updated
August 9, 2018
Sponsor
The Hong Kong Polytechnic University
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
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Effectiveness of a Combined Pressure and Silicone Intervention for Hypertrophic Scar Treatment
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