Back to results

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

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

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

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

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

Learn more about this trial

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

We'll reach out to this number within 24 hrs