The Efficacy of Prophylactic Use of Extract of Allium Cepae, Allantoin and Heparin in Patients With Proven Scar Development After Excision of Previous Scar
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- POSAS observer score change will be assessed by POSAS observer scale (The Patient and Observer Scar Assessment Scale v2.0) just prior to second c-section and at 6,12 and 24 weeks following the c-section.
研究概览
简要总结
To investigate the efficacy of prophylactic use of a topical gel containing extract of allium cepae, allantoin and heparin after surgical removal of the primary cesarean scar in the second cesarean section.
详细描述
120 patients who are admitted for the second cesarean delivery, not taking prophylactic medication after the first cesarean section, whose scar development and measurements are taken will be included in the study. First caesarean section scars will be removed surgically for all patients. 60 out of 120 patients (treatment group) will use prophylactic topical scar gel 2 times in a day, and remaining 60 patients (control group )won't use. The efficacy of the drug will be evaluated by taking strict measurements of the incision and POSAS (The Patient and Observer Scar Assessment Scale) and Vancouver Scales at 6.12 and 24 weeks.
Steps;
- Observation of the primary cesarean scar by taking scar measurements and using Vancouver and POSAS scales.
- Surgical removal of the primary cesarean scar in the second cesarean section.
- 24 weeks topical application of gel containing extract of allium cepae, allantoin and heparin(only treatment group).
- Observation of the skin incision at 6,12 and 24 weeks by taking scar measurements with using Vancouver and POSAS scales.
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
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients who are admitted for the second cesarean delivery
- •Not to use topical scar gel after the first c-section
排除标准
- •chronic illness, immunosuppressive therapy or smoking
- •development of wound infection during the second c- section
- •allergies and hypersensitivities to components of the gel
研究组 & 干预措施
Patients using contractubex
Scar excision will be performed in second c-section for 60 patients and these patients will use prophylactic topical scar gel containing extract of allium cepae, allantoin and heparin two times in a day.
干预措施: extract of allium cepae, allantoin and heparin (Drug)
Patients using contractubex
Scar excision will be performed in second c-section for 60 patients and these patients will use prophylactic topical scar gel containing extract of allium cepae, allantoin and heparin two times in a day.
干预措施: Scar excision (Procedure)
Patients not using contractubex
Scar excision will be performed in second c-section for 60 patients and these patients will not use prophylactic topical scar gel containing extract of allium cepae, allantoin and heparin.
干预措施: Scar excision (Procedure)
结局指标
主要结局
POSAS observer score change will be assessed by POSAS observer scale (The Patient and Observer Scar Assessment Scale v2.0) just prior to second c-section and at 6,12 and 24 weeks following the c-section.
时间窗: just prior to second c-section and at 6,12,24 weeks
POSAS patient score change will be assessed by POSAS patient scale (The Patient and Observer Scar Assessment Scale v2.0) just prior to second c-section and at 6,12 and 24 weeks following the c-section.
时间窗: just prior to second c-section and at 6,12,24 weeks
Vancouver scar score change will be assessed by Vancouver scar scale just prior to second c-section and at 6,12 and 24 weeks following the c-section.
时间窗: just prior to second c-section and at 6,12,24 weeks
次要结局
未报告次要终点