Optimal Wound Care After Simplex or Modified Radical Mastectomy With or Without Axillary Lymphadenectomy Placement of a Drain Versus the Use of Adaptive Skin Sutures; a Prospective Randomised Study
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Total amount of sera withdrawn from the wound cavity
研究概览
简要总结
The objective of this prospective randomized study is to perform qualitative and quantitative comparisons between the insertion of traditional suction drains (Arm: Suction drain) versus the application of absorbable adaptive sutures (Arm: Adaptive suture) following simplex mastectomy or modified radical mastectomy in the light of the total volume of withdrawn serum from wound cavity, the extent of early postoperative analgesic requirements and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female patients with primary unilateral, stage 0, I or II, T3N1M0 breast cancer necessitating simple or modified radical mastectomy
排除标准
- •age above 75 years and bad general state
- •pregnancy
- •autoimmune disease
- •non-radical excision
- •mastitis carcinomatosis
- •lymphangitis carcinomatosis
- •wound infection necessitating treatment
研究组 & 干预措施
Suction drain
Patients in Arm A undergo simplex mastectomy or modified radical mastectomy. One plastic Redon drain (16 Ch) is placed after simplex mastectomy and two plastic Redon drains (16 Ch each) following modified radical mastectomy.
干预措施: Insertion of suction drain(s) following mastectomy (Procedure)
Adaptive suture
Following mastectomy, wound cavity is closed with adaptive skin sutures. No suction drain is inserted.
干预措施: Adaptive skin sutures. (Procedure)
结局指标
主要结局
Total amount of sera withdrawn from the wound cavity
时间窗: 4 weeks
By each follow-up visit within the indicated time frame, the punctuated serum is collected and its volume is measured by a measuring cylinder acquired from the Pharmacy Department and data is recorded. At the end of the follow-up period, the total amount of serum (mL) is documented.
次要结局
- Number of punctions following the removal of suction drain, and total volume of punctuated seroma (mL)(4 weeks)
- Cost analysis(4 weeks)
- Extent of early postoperative analgesic requirements(4 days)
- Rate of local wound complications.(4 weeks)
- Assessment of quality of life in the early postoperative period(4 weeks)
- Mobility of the shoulder on the side of the operated side(4 weeks)
研究者
Dr. Zoltan Matrai
principal investigator
National Institute of Oncology, Hungary