Preliminary Clinical Evaluation of a Silicone Gel for Scar Management in a Taiwanese Population

疤痕矽膠運用於台灣人口疤痕之初步臨床試驗

王惠琳(Hu-Lin Christina Wang) ； 林之昀(Chih-Yun Lin) ； 游彥辰(Yen-Chen Yu) ； 阮廷倫(Tyng-Luen Roan) ； 陳右昇(Yo-Shen Chen) ； 張克中(Ke-Chung Chang) ； 林佐武(Tsuo-Wu Lin) ； 湯月碧(Yueh-Bih Tang)

《臺灣整形外科醫學會雜誌》 27卷4期 (2018/12) Pp. 254-262

摘要

Background: The efficacy of topical silicone treatment on scars has been previously studied, and various forms of silicone gels are available on the market. However, the efficacy of topical silicone treatment on scars has not yet been explored in the Taiwanese population. Aim and Objectives: To evaluate the efficacy of a topical self-drying silicone gel for treating scars in Taiwanese people. Materials and Methods: Between September 2013 and June 2015, a randomized, prospective, cross-sectional study was performed with 30 patients. The patients applied SavDerm^® silicone gel for a total of 16 weeks according to the group to which they were assigned: patients in group A applied the gel and were evaluated before and after using SavDerm^® silicone gel on the entire scars. Patients in group B applied the silicone gel over half of the scar while leaving the other half untreated. Each patient was followed up every four weeks and evaluated according to the Nedelec-modified Vancouver Scar Scale as well as for itchiness. Results: During the 16-week follow-up, all scars that were treated with SavDerm^® silicone gel showed improvement on itchiness, vascularity, and pliability starting from the 4^(th) week. Decrease in pigmentation was noted starting from the 8^(th) week in group A; however, there were no statistically significant changes in the scar height. In group B, improvement on itchiness, vascularity, pliability, and scar height were noted since the 8^(th) week of use, although the differences were statistically insignificant. Conclusion: The results of this study support that the appearance of scars may be further improved by applying silicone gel for a period of 4 months or longer comparing with untreated scars. A randomized, double-blind, controlled study with a larger population sample should be considered in the future for more objective results.

關鍵字

scar ； silicone gel

並列摘要

背景：許多人皆因外傷或手術在身體外觀產生疤痕，矽材料對疤痕的淡化及護理已在多數臨床報告中被證實其功效，市場也推出各種不同型態之矽材料除疤商品像是矽膠片、矽凝膠或是膏狀劑型等，但據我們所知(to the best of own knowledge)沒有針對本國人使用矽凝膠來淡化疤痕的系統研究。目的及目標：研究疤痕矽凝膠是否可預防國人疤痕及其淡化疤痕之效果。材料及方法：在2013年9月至2015年6月期間，對30例患者進行了隨機前瞻性橫斷面研究。患者按照他們分配的組，使用舒敷貼疤痕凝膠16週：A組患者在使用前和使用舒敷貼疤痕凝膠後進行疤痕評估。B組患者的疤痕一半使用舒敷貼疤痕凝膠一半不做任何處理。每位病人每四週追蹤一次，並根據Nedelce修改的溫哥華疤痕量表Vancouver Scar Scale(VSS)進行評估。結果：在16週的追蹤期間，使用舒敷貼疤痕凝膠的疤痕有顯著改善。從第4週開始注意到血管及柔軟度的改善，A組的第8週開始就明顯減少色素沉著。然而，疤痕高度在統計學上沒有顯著變化。而在B組中，使用第8週後疤痕的血管分佈、柔軟度及疤痕高度有改善，但在統計學上不顯著。結論：根據本研究的結果，可以通過使用矽膠至少4個月的時間來改善手術，創傷或燒傷後疤痕的出現。未來應考慮採用較大群體樣本的隨機雙盲對照研究，以獲得更客觀的結果。