Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Hip Arthropathy
  • Hypertrophic Scar
  • Knee Arthropathy
Type
Interventional
Phase
Early Phase 1
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Masking Description: 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.Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

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 p...

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.

Tracking Information

NCT #
NCT03849274
Collaborators
The Hong Kong Polytechnic University
Investigators
Not Provided