Department of Pharmacology, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India,
Dermatol Ther (Heidelb). 2013 Dec;3(2):157-67. doi: 10.1007/s13555-013-0036-8. Epub 2013 Nov 20.
Scar formation is a natural part of the healing process that occurs when the skin repairs wounds caused by burns, trauma, surgery or disease. The appearance of scars often leads to adverse psychological effects, loss of self-esteem and the associated stigmatism and diminished quality of life. Silicones are emerging as the standard treatment for prevention of a wide range of scars. The present study evaluated the safety and efficacy of an advanced formula topical silicone gel for prevention of post-operative hypertrophic and keloid scars.
An open-label prospective trial was conducted. Patients who had undergone prior surgery (10 days-3 weeks) and having recent post-surgical scars were enrolled. Patients were asked to apply the gel twice daily to the affected areas for 3 months. Pigmentation, vascularity, pliability, height of scar and pain and pruritus in the scar were assessed. Photographs of scars were taken before commencement of treatment and at follow-up visits.
A total of 36 patients were enrolled. At baseline, height of the scar was 2-5 mm in 57.6 % (19/33) of the subjects which was reduced in subsequent visits (P < 0.05). Hyperpigmentation (score 3) was present in 91% (30/33) of patients at baseline and was reduced to normal (score 0) after 2 months of treatment in 40% (6/14) of patients (P = 0.0313). Vascularity (54.6%, 18/33) at baseline was also reduced over the 3 months period (P = 0.0313) A significant decrease (30%, 3/10) (P = 0.0313) in pliability was seen after 3 months of treatment from the baseline (57.6%, 19/33). Only two patients reported pruritus and pain at the baseline visit; one patient reported improvement after treatment. Itching was reported as an adverse drug reaction in two patients.
These preliminary findings suggest that advanced formula silicone gel is safe and effective in the prevention of hypertrophic and keloid scars; however, larger, controlled studies are warranted.
疤痕形成是皮肤修复烧伤、创伤、手术或疾病造成的伤口时的自然愈合过程。疤痕的出现常常导致不良的心理影响、自尊心丧失以及相关的耻辱感和生活质量下降。硅酮类物质正成为预防多种疤痕的标准治疗方法。本研究评估了一种先进配方的外用硅酮凝胶预防术后增生性和瘢痕疙瘩的安全性和有效性。
进行了一项开放性、前瞻性试验。招募了先前接受过手术（10 天-3 周）且有近期术后疤痕的患者。要求患者每天两次将凝胶涂抹在受影响的区域，持续 3 个月。评估了色素沉着、血管性、柔韧性、疤痕高度以及疤痕的疼痛和瘙痒。在开始治疗前和随访时拍摄疤痕照片。
共纳入 36 名患者。在基线时，33 名患者中有 57.6%（19/33）的疤痕高度为 2-5 毫米，在随后的随访中有所降低（P<0.05）。基线时 91%（30/33）的患者存在色素沉着（评分 3），在治疗 2 个月后，40%（6/14）的患者恢复正常（评分 0）（P=0.0313）。基线时的血管性（54.6%，18/33）在 3 个月期间也有所降低（P=0.0313）。在治疗 3 个月后，与基线相比，柔韧性显著降低（30%，3/10）（P=0.0313）。基线时有 2 名患者报告瘙痒和疼痛，1 名患者在治疗后报告症状改善。有 2 名患者报告瘙痒是一种药物不良反应。
这些初步发现表明，先进配方硅酮凝胶在预防增生性和瘢痕疙瘩方面是安全有效的，但需要更大规模的、对照的研究。
