The Risk of Postoperative Wound Complications Following the Use of Avelle Negative Pressure Wound Therapy in Patients Undergoing Mastectomy and Flap fiXation: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 162
- 试验地点
- 2
- 主要终点
- Number of patients with post-operative wound complications
研究概览
简要总结
To evaluate the risk of postoperative wound complications following the use of Avelle negative pressure wound therapy in patients undergoing mastectomy and flap fixation, which might serve as a basis for a randomized controlled trial
详细描述
Rationale:
Patients and breast cancer surgeons are frequently confronted with complications after mastectomy. These complications are manifold and mainly consist of: surgical site infections, seroma, wound dehiscence and wound necrosis. These complications are caused by numerous variables and therefore a multifactorial approach is required. Due to extensive research over the years, insight has been gained in how to reduce the rate of surgical site infections and wound healing problems. For example, pre-operatively and intra-operatively the complication rate can partly be influenced by optimizing intrinsic patient factors before surgery and using prophylactic antibiotics (1). There is however room for improvement in the postoperative phase. Negative pressure wound therapy (NPWT) has proven to be useful in reducing wound complications in all sorts of wounds. Limited evidence has been published on NPWT after breast cancer surgery and the effect of such in reducing wound complications.
This is a pilot study to evaluate the effect of negative pressure wound therapy in reducing postoperative wound complications after mastectomy, which might serve as a basis for a randomized controlled trial..
Objective:
To evaluate the risk of postoperative wound complications following the use of Avelle negative pressure wound therapy in patients undergoing mastectomy and flap fixation, which might serve as a basis for a randomized controlled trial
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
- •Older than 18 years
- •Female sex
- •Indication for mastectomy or modified radical mastectomy
排除标准
- •Patients undergoing breast conserving therapy
- •Patients undergoing direct breast reconstruction
- •Unable to comprehend implications and extent of study and sign for informed consent
- •Participation in other study
结局指标
主要结局
Number of patients with post-operative wound complications
时间窗: During the first three postoperative months
Number of patients with post-operative wound complications defined as follows: 1. Surgical site infection (SSI) is defined as redness, pain, heat or swelling at the site of the incision or by the drainage of pus. Infection rate will be measured by A) the need for antibiotics, B) seroma aspiration due to infection or C) surgical drainage during the first three postoperative months. 2. Wound necrosis. Defined as a wound with necrotic tissue that consists of an accumulation of dead cells, tissue and cellular debris and often requires debridement. 3. Wound dehiscence or breakdown defined as a wound that ruptures along a surgical incision and the edges of the wound no longer align.
次要结局
- Number of unplanned visits to the ER or breast cancer clinic(During the first three postoperative months)
- Number of patients with clinically significant seroma(During the first three postoperative months)
研究者
James van Bastelaar
Surgeon, Principal Investigator, MD, PhD
Zuyderland Medisch Centrum