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

NCT03849274 | Completed Early Phase 1

• 1 other identifier: CUHK_2018.487-T
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Knee Arthropathy; Hip Arthopathy; Hypertrophic Scar; Smart Scar Care Pad; Pressure Garment

Outcome Measures

Primary Outcomes (3)

• Changes from baseline hypertrophic Scar Thickness at 1 months post-surgical to total knee/hip arthroplasty

  Using an ultrasound machine, thickness of scar is aggregately measured to the average of 3 points: the center of the inner ring, 5 mm on both side of the centre point, which reflected the points of circumference of the selected scar sites.

  1 month post total knee/hip arthroplasty operation

• Changes from baseline hypertrophic Scar Thickness at 3 months post-surgical to total knee/hip arthroplasty

  Using an ultrasound machine, thickness of scar is aggregately measured to the average of 3 points: the center of the inner ring, 5 mm on both side of the centre point, which reflected the points of circumference of the selected scar sites.

  3 month post total knee/hip arthroplasty operation

• Changes from baseline hypertrophic Scar Thickness at 6 months post-surgical to total knee/hip arthroplasty

  Using an ultrasound machine, thickness of scar is aggregately measured to the average of 3 points: the center of the inner ring, 5 mm on both side of the centre point, which reflected the points of circumference of the selected scar sites.

  6 month post total knee/hip arthroplasty operation

Secondary Outcomes (21)

• Changes of scar vascularity and pigmentation at 1 month post-surgical to total knee/hip arthroplasty

  1 month post total knee/hip arthroplasty operation

• Changes of scar vascularity and pigmentation at 3 months post-surgical to total knee/hip arthroplasty

  3 months post total knee/hip arthroplasty operation

• Changes of scar vascularity and pigmentation at 6 month post-surgical to total knee/hip arthroplasty

  6 month post total knee/hip arthroplasty operation

• Changes of scar elasticity at 1 month post-surgical to total knee/hip arthroplasty

  1 month post total knee/hip arthroplasty operation

• Changes of scar elasticity at 3 months post-surgical to total knee/hip arthroplasty

  3 months post total knee/hip arthroplasty operation

Study Arms (3)

Smart Scar Care Pad+Pressure Garment

EXPERIMENTAL

For experiment group, subject will be intervened by SSCP plus PG

Combination Product: Smart Scar Care Pad=Pressure Garment; Device: Pressure Garment

Pressure Garment

ACTIVE COMPARATOR

For control group, subject will be intervened by conventional PG only

Device: Pressure Garment

Non-eligible patients (with VSS less than 4)

NO INTERVENTION

Non-eligible subjects with VSS less than 4 will be followed up for 6 months and assessment results will be recorded.

Interventions

Smart Scar Care Pad=Pressure Garment COMBINATION_PRODUCT

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)

Smart Scar Care Pad+Pressure Garment

Pressure Garment DEVICE

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

Pressure Garment; Smart Scar Care Pad+Pressure Garment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (age over 18 years old) undergoing TKR and THR within 6 weeks;
• Adult who is able to provide written consent, is cooperative and compliant with the treatment and assessment regime;
• 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.

You may not qualify if:

• The HS area has an open wound or infection, or HS area is local flap or skin graft area;
• The HS area intends to be treated with steroid injections or other interventions (such as traditional Chinese medicine or laser therapy)
• The patients with co-morbidities that might affect their compliance to treatment such as dermatological disorders.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• The Hong Kong Polytechnic University: collaborator

Study Sites (1)

Department of Orthopaedics & Traumatology

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Cicatrix, Hypertrophic

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All subjects will be asked to removed all the treatment materials before they entered the assessment rooms to ensure the blinding of the assessor. The ultrasound data will be processed and analysed by blinded analysts.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professional Consultant

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 21, 2019
• Study Start: January 31, 2020
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: March 15, 2022

Record last verified: 2022-03

Locations

HK (1)