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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-31

Study Completion Date

2021-07-31

Brief Summary

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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.

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Detailed Description

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Hypertrophic scar (HS) is a challenging yet common complication of dermal injuries such as burns, surgeries, and trauma. It is characterized as a raised, rigid, hyper-vascular, and abnormally pigmented scar confined within the border of the initial injury. The induced aesthetic defect and impaired physical function could adversely affect quality of life.1 Pressure therapy (PT) and silicone therapy are recommended as first-line non-invasive treatments HS.

Recent reviews suggested PT was able to decrease scar height and erythema3,4. The inconclusive outcome results from fact that seldom research address the issue of adequate pressure dosage, which is essential for the treatment effect of PT. It is recommended that an interface pressure of 15-25 mmHg should be given and maintained through a 23 hrs/day wearing regime in order to achieve optimal treatment outcomes5. However, maintaining adequate pressure dosage through pressure garment alone is usually uncomfortable and sometimes impossible, especially over bodily concave area. Therefore, pressure inserts are used in conjunction with pressure garment to increase local pressure6. Despite the documented use of pressure inserts in various journals, pressure garment alone remains the mainstream treatment for hypertrophic scar.

Cochrane review conducted on silicone gel sheet (SGS) revealed SGS's ability in reducing scar thickness and improving scar color, but insufficient data on its effect on scar pliability5. SGS are commonly used to occlude and provide hydration to scar tissues.5, 6 They are mainly used for small scars or surgical scars. They are generally costly and thin in physical form, rendering them incapable of exerting sufficient pressure.

The joint effectiveness of these two treatment modalities in scar management is always drawing the interests from researchers. Various studies reported that enhanced effectiveness could be achieved through the combination of PT and SGS especially in terms of scar pliability, though all subjectively measured6-8. Therefore, there is an urging need to establish the effectiveness of the combination of these two treatments through an RCT.

In order to address the adequate pressure as well as the silicone gel sheeting effect at the same time, a newly invented insert material, the Smart Scar Care Pad (SSCP), is adopted in this study as treatment modality. The Smart Scar Care Pad is especially designed with a rubbery silicone stiffener layer and medical grade silicone gel lining layer underneath. The medical grade silicone gel lining layer underneath serves as the occlusion layer. The rubbery silicone stiffener layer is designed with numerous studs. By cutting the individual studs into gradient height, the Smart Scar Care Pad (SSCP), creates tailor made localized pressure under pressure garment. Studs are also aligned in honey cone style in order to maximize conformability over different bodily contours. In that case, the Smart Scar Care Pad (SSCP) not only increases local pressure but also provides occlusion to HS tissue.

Conditions

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Knee Arthropathy Hip Arthropathy Hypertrophic Scar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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Smart Scar Care Pad+Pressure Garment

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

Group Type EXPERIMENTAL

Smart Scar Care Pad=Pressure Garment

Intervention Type 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)

Pressure Garment

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Pressure Garment

Intervention Type DEVICE

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

Non-eligible patients (with VSS less than 4)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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)

Intervention Type COMBINATION_PRODUCT

Pressure Garment

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Adult (age over 18 years old) undergoing TKR and THR within 6 weeks;
2. Adult who is able to provide written consent, is cooperative and compliant with the treatment and assessment regime;
3. 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.

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes