Impact of Iron Stores on Wound Healing in Plastic Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Proportion of good breast tissue healing on each breast
研究概览
简要总结
In breast reduction surgery, delayed wound healing may increase surgical site infections, cutaneous necrosis and may be related to psychological harm.Some risk factors have been identified : smoking, diabetes, overweight. A normal healing involve cellular and biochemical reactions in which iron plays an important role such as cellular respiration, redox reactions and regulation of genes involved in the cell cycle. This trial will study the relationship between iron stores and postoperative wound healing after bilateral breast reduction surgery in patients without preoperative anaemia.The primary outcome of this trial is the comparison of wound healing at post operative day 15, between patients with and without iron deficiency.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •age >18 years
- •scheduled bilateral breast reduction surgery
- •biological exams with ferritin and transferrin saturation coefficient taken the day before surgery
- •No anemia : haemoglobin >=12g/dL (preoperative biological assessment )
- •if genetic disease of haemoglobin, haemoglobin between 10 and 12g/dL and no Anaemia by iron deficiency
- •absence of clinical inflammatory syndrome (no clinical signs of infection or no fever)
- •non-opposition of the patient to participate
排除标准
- •Anaemia by iron deficiency
结局指标
主要结局
Proportion of good breast tissue healing on each breast
时间窗: 15 days after surgery
Good healing is defined as a score of 0, 1 or 2 on a 16 points-specifc scale. The scale evaluate proportion of disunity for periareolar vertical and horizontal incisions
次要结局
- Evaluation of healing on the 16 points specific scale(15 days after surgery)
- Proportion of closed drainage orifices(15 days after surgery)
- Proportion of early complications(up to 15 days after surgery)
- Correlation between serum ferritin levels before surgery and score on the healing scale(15 days after surgery)
- Intra-class correlation coefficient for the healing scale(15 days after surgery)