Effect of High Doses of Vitamin C on the Tissular Reparation (Healing) in Patients Under Surgery in the "Hospital de Los Valles".
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Evaluation of linear scars
研究概览
简要总结
This is a prospective, randomize, double-blind, and placebo-controlled study to evaluate in patients with clinical criteria for any of the following open surgical procedure: (1) cesarean section; (2) aesthetic surgery like abdominoplasty; (3) orthopedic surgery; and (4) abdominal open surgery [excluding laparoscopic procedures] will be invited to receive either a high dose of vitamin C (12.5 g) three times (48 h pre-surgery, immediately before surgery and 48 h post-surgery) or its placebo, to evaluate the tissue repair process using an international validated instrument named Patient and Observer Scar Assessment Scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older than 18 years.
- •Susceptible for any of the following surgical procedures: (1) cesarean section; (2) aesthetic abdominal plastic surgery; (3) orthopedic prosthetic replacement surgery
- •Voluntary consent to participate
排除标准
- •Known allergy to the vitamin C
- •Known problems with wounds healing
- •Kidney disease (including lithiasis) or gout
结局指标
主要结局
Evaluation of linear scars
时间窗: third assessment, three months after surgery
Patient and Observer Scar Assessment Scale (it evaluates in a 0 to 10 scale: vascularity, pigmentation, thickness, relief, pliability and surface area)
次要结局
未报告次要终点
研究者
Enrique Teran
Principal Investigator
Universidad San Francisco de Quito