EvaLuating negAtive pressUre Wound theRapy in brEast coNserving Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Surgical complications
研究概览
简要总结
Negative pressure wound therapy (NPWT) could improve surgical outcomes and reduce complications like SSI, wound dehiscence and seroma in closed surgical wounds. To date, NPWT was not evaluated in patients undergoing breast conserving surgery without direct reconstruction.Therefore, the aim of this trial is to evaluate the feasibility of NPWT after surgery and its effects on postoperative complications.
详细描述
Rationale:
Negative pressure wound therapy (NPWT) could improve surgical outcomes and reduce complications like SSI, wound dehiscence and seroma in closed surgical wounds. Complication rate after breast conserving surgery for breast cancer is 2-17%, surgical site infections (SSI) being the most common. To date, NPWT was not evaluated in patients undergoing breast conserving surgery without direct reconstruction. Therefore, in this trial, the aim is to evaluate the feasibility of NPWT after breast conserving surgery and its effects on postoperative complications.
Objective and study parameters:
Primary objective is to compare surgical site complications in patients with and without NPWT. Secondary objective is to assess the number of re-interventions, unplanned visits and pain scores.
Study design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Eighteen years or older.
- •Female sex.
- •Indication for breast conserving surgery, with or without sentinel lymph node biopsy.
排除标准
- •Undergoing mastectomy or modified radical mastectomy.
- •Undergoing direct breast reconstruction.
- •Patients with a pacemaker, intra cardiac defibrillator (ICD) or other medical device in the proximity of the wound area, due to the magnet in the PICO® device.
- •Unable to comprehend implications and extent of the study and/or unable to sign for informed consent.
- •Participation in another breast cancer surgery related clinical trial.
结局指标
主要结局
Surgical complications
时间窗: 3 months after surgery
Number of surgical complications, including clinically significant seroma, surgical site infections, wound dehiscence or wound necrosis.
次要结局
- Need of re-intervention(3 months after surgery)
- Number of unscheduled visits to the emergency department or outpatient clinic(3 months after surgery)
- Pain scores during NPWT(one week after surgery)