Silicone Gel Versus Onion Extract Gel as Prevention for Postsurgical Scars: a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Scar scale (VSS and BIQ)
研究概览
简要总结
Hypertrophic or keloid scars develop for about 39% to 68% of patients after surgery. The subjective opinion of the patient regarding the scar will often constitute the standard for judging the success or failure of the procedure. Surgical scars are not only a cosmetic concern but they can also cause pain, itching, discomfort, contracture, and other functional impairment. Various treatment options exists for treating hypertrophic scars and keloids, including intralesional steroid injection, dermabrasion, pressure therapy, surgical excision, radiotherapy, cryotherapy, pulse dye, and carbon dioxide laser ablation. However, these treatments often require multiple visits and have limited success. Therefore, prevention and early recognition of hypertrophic scars and keloids are very important in their management.
Among preventive treatments available, silicone gel and onion extract gel have been marketed as products to improve the appearance and texture of surgical scars. Despite its popularity, data demonstrating the efficacy of these gels are lacking. Furthermore, there is no comparative study of silicone gel and onion extract gel for preventing postsurgical hypertrophic or keloid scars. The investigators therefore conducted this randomized controlled trial to compare the efficacy of silicone gel and onion extract gel for the prevention of postsurgical hypertrophic scars. The investigators also compared patient compliance and side effect between two topical gels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •over 18 years of age,
- •at least 3 cm sized surgical wound in total length,
- •nonpregnant at the time of presentation (i.e., negative for urine pregnancy test or last menstrual period within the last 4 weeks),
- •able to read and write informed consent and questionnaire.
排除标准
- •women who received nearly scar-free surgery such as laparoendoscopic single-site (LESS) surgery or natural orifice transluminal surgery (NOTES);
- •women who developed surgical complications such as wound infection
- •women who had a history of hypertrophic or keloid scarring in abdomen
- •women who were taking chemotherapeutic agents or other medications that would affect wound healing, such as steroids
- •women who had comorbidities such as diabetes, contractive skin disorders (e.g., scleroderma), or active dermatologic conditions
- •women who had allergy to silicone or onion.
研究组 & 干预措施
Silicone gel
Silicone gel (Kelo-cort™; Advanced Bio-Technologies, Silverdale, WA, USA) From the day of suture removal, the treatment was applied three times daily for 3 months.
干预措施: Silicone gel Kelo-cort™; (Drug)
Onion extract gel
Onion extract gel (Contractubex™; Merz Pharma, Frankfurt, Germany) From the day of suture removal, the treatment was applied three times daily for 3 months.
干预措施: Onion extract gel Contractubex™ (Drug)
结局指标
主要结局
Scar scale (VSS and BIQ)
时间窗: 3 months after surgery
次要结局
未报告次要终点