Smart Scar Care Pad: An Innovated Silicone-Based Insert That Improved Severe Hypertrophic Scar by Integrating Optimal Pressure and Occlusion Effects

Objective: Inserts are typically used in conjunction with pressure garment to improve the outcomes of hypertrophic scar (HS) treatment. However, the types of insert materials currently available have many limitations, thus hindering their therapeutic effect. An innovative insert material, the Smart Scar Care Pad (SSCP), was invented to maximize treatment outcomes through enhanced compression and occlusion. The study aimed to investigate the properties of the SSCP and its efficacy to serve as a suitable insert material for HS management. Approach: The physical properties and biocompatibility of SSCP were examined. A self-controlled clinical study of 45-day intervention using SSCP in comparison with Plastazote was conducted on 25 subjects with HS. Study outcomes included scar parameters measured both subjectively and objectively and patient feedback questionnaire. Results: The SSCP demonstrated equivalent and even superior performance when compared with commercial products in tests of biological safety and physical properties. Both arms demonstrated significant time effects on Vancouver Scar Scale total score (p = 0.000), melanin score (p = 0.042), pliability (p = 0.039), and hydration score (p = 0.013). Significant intervention and time interaction effect was found in the pliability (p = 0.048). From the feedback questionnaire, patients reported that SSCP was more conformable and there was less displacement during movement (p = 0.040) compared with conventional insert. Innovation: The SSCP is the first insert that combined the pressure enhancing effect of a traditional pressure insert and occlusion effect of silicone insert. Conclusion: The SSCP can serve as a safe and effective insert material in HS treatment, especially in improving HS pliability.