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SMART Dressing for Hypertrophic Scar Treatment Post-Total Knee/Hip Arthroplasty

NCT03849274 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-03-15

No results posted yet for this study

Summary

Pressure therapy (PT) and silicone therapy are recommended as first-line non-invasive treatment for Hypertrophic Scar (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) + conventional Pressure Garment (PG) versus conventional Pressure Garment (PG) alone in the management of HS in adult with total hip replacement (THR) and total knee replacement (TKR). This study also aims to find out the prevalence of hypertrophic scar among patients with THR and TKR. This study is a randomised controlled trial with two parallel arms, with allocation ratio (Experimental: Control) of 1: 1 in order to establish the superiority of SSCP + PG over PG. Subjects with hypertrophic scar will be randomly assigned to either treatment or control group. The subjects in the treatment group will be provided with the SSCP and PG for treatment, whereas the subjects in the control group will be prescribed only the PG. The treatment will last for a total of 6 months. A variety of objective outcome measures will be used to analysis the treatment effect.

Conditions

  • Knee Arthropathy
  • Hip Arthropathy
  • Hypertrophic Scar

Interventions

COMBINATION_PRODUCT

Smart Scar Care Pad=Pressure Garment

Smart Scar Care Pad (SSCP) + conventional Pressure Garment in the management of HS in adult with total hip replacement (THR) and total knee replacement (TKR)

DEVICE

Pressure Garment

Conventional Pressure Garment (PG) alone in the management of HS in adult with total hip replacement (THR) and total knee replacement (TKR)

Sponsors & Collaborators

  • The Hong Kong Polytechnic University

    collaborator OTHER

  • Chinese University of Hong Kong

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-31
Primary Completion
2021-07-31
Completion
2021-07-31

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03849274 on ClinicalTrials.gov