The Efficacy of SurgiGuard in prevention of seroma formation after total mastectomy; A prospective randomized trial
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 94
研究概览
简要总结
Seromas frequently develop in patients who undergo total mastectomy with node surgery. We aimed to prospectively explore whether use of oxidized regenerated cellulose (ORC, SurgiGuard®) affects seroma formation after total mastectomy with node surgery (sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND)). Ninety four breast cancer patients were enrolled in the study who underwent total mastectomy with ALND or SLNB. The patients were randomized into two groups, one treated with ORC plus closed suction drainage and the other with closed suction drainage alone. Mean drainage volume was slightly lower in the ORC group on postoperative day 1 (123 ± 54 vs 143 ± 104 ml), but was slightly higher at all other time points; however, these differences were not significant. Mean total drainage volume in patients treated with ORC plus drainage did not differ from that of patients treated with drainage alone (1134 ± 507 ml vs 1033 ± 643 ml, P=0.486). In conclusion, Use of ORC (SurgiGuard®) did not significantly alter the risk of seroma formation.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- o Limit 至 o Limit（—）
- 性别
- Female
入选标准
- •1)Patients scheduled to undergo total mastectomy and node surgery (axillary lymph node dissection or sentinel lymph node biopsy) who were diagnosed with invasive breast cancer.
- •2)Patients who understand the goal and the process of the trial and who want to participate in the trial with written informed consent.
- •3)No age limitation.
排除标准
- •1)Patients who had a personal history of hypersensitivity or allergic reaction to anticoagulants
- •2)Patients with obesity (defined as a body mass index >30 kg/m2)
- •3)Patients who received neoadjuvant chemotherapy or planned to undergo immediate breast reconstruction
- •4)Patients who have plan to palliative surgery