Prevention of Postoperative Complications by Negative Pressure Therapy After Complex Breast Cancer Surgery: a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 254
- 试验地点
- 12
- 主要终点
- Rate of patients experiencing postoperative wound healing complication
研究概览
简要总结
There is little scientific data concerning the use of negative pressure therapy after immediate breast reconstruction.
That strategy of treatment-reconstruction has expanded increasingly since the last years.
The current literature reports only 3 studies on the use of preventive negative pressure therapy in oncologic breast surgery.
Moreover, all three are retrospective, case-control studies with serious limitations.
The largest published series reports a reduction in the overall complication rate from 15.9% to 8.5%, and a significant reduction in several criteria: infection, scar dehiscence and necrosis. However, the study presents significant biases, with non-comparable populations in terms of comorbidities, surgical procedure performed, inclusion periods (and therefore experience in performing oncological surgery).
There was also a high probability of under-assessment or postponement of post-operative complications, which is typical of published retrospective surgical studies.
The published results therefore strongly encourage further investigation of negative pressure therapy in oncological breast surgery.
详细描述
In 2022, excisional surgery is still one of the mainstays of breast cancer treatment. The excisional surgery is often combined with adjuvant treatments, which may include medical treatments such as chemotherapy, targeted therapies and immunotherapy, hormone therapy and radiotherapy. All these treatments have toxicities that impact on patients' quality of life.
One of the main complications of surgery is scarring. The rate is around 2% for "simple" breast surgery (conservative breast surgery - total mastectomy). This rate can rise sharply in the case of "complex" breast surgery, such as high-level oncoplasty, or mastectomy with Immediate Breast Reconstruction (IBR). This rate of surgical wound complications (ischemia, necrosis, dehiscence, infection) reached 20% in our local series of Immediate Breast Reconstruction (IBR) by prosthesis. This rate may exceed 30% in some series, depending on the surgical technique and the population, in cases of smoking, diabetes, previous radiotherapy, obesity and large breast volume. The increasing prevalence of these risk factors in the population means that scarring disorders must be taken into account in daily cancer care.
The impact of these scarring disorders is manifold:
- Delayed initiation of adjuvant therapy with an impact on overall survival.
- Cosmetic impact of scarring
- Possible loss of prosthetic breast reconstruction
- Patient dissatisfaction, with increased burden of care
- Overall impact on patient quality of life
- Economic impact linked to the length of care over time (consumption of dressing materials and personal time) Preventing the onset of wound-healing disorders is therefore vital in order to avoid these multiple consequences for the patient and the healthcare system.
In breast surgery, the use of preventive NPT (Negative Pressure Therapy) has been little studied. The NPT has been used mainly in cosmetic surgery procedures such as breast reduction, with results in favor of NPT. The most comprehensive study is a multicenter randomized trial which included 200 patients scheduled for bilateral breast reduction. In this trial, the comparison was made between the 2 breasts, each patient being her own control. The calculation of the number of subjects was based on a reduction in the complication rate from 20% to 10% (i.e., a 50% reduction). The study was positive, showing a reduction in the dehiscence rate at day 21 from 26% to 16%. In this study, patients were under-selected, and around 40% had risk factors for complications. A second randomized study, with similar methodology and judgment criteria, included 32 patients undergoing bilateral breast reduction. The results of this study are significant, but unfortunately there weren't much detail in the publication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Female ≥ 18 years
- •Patient with unilateral invasive or in situ breast carcinoma
- •Patient with or without neoadjuvant treatment
- •Patient presenting an indication for complex breast surgery by mastectomy with immediate breast reconstruction by implant or oncoplasty by T-shaped mammoplasty.
- •Patient presenting at least one of the following risk factors for scarring disorders:
- •Obesity with Body Mass Index BMI ≥ 30 and/or Cup size ≥ E
- •Active smoking or smoking cessation for less than one month
- •History of homolateral breast radiotherapy
- •Long-term corticosteroid therapy
- •Patient to have signed informed consent prior to study entry
- •Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- •Patient affiliated with a health insurance plan.
排除标准
- •Legal incapacity or limited legal capacity. Medical or psychological conditions preventing the patient from completing the study or signing the consent form.
- •Pregnant or breast-feeding patient as determined in medical records as part of standard patients care and follow-up
- •Patient under guardianship or safeguard of justice
- •Patient participating in an interventional study with the objective of wound healing
- •Any concurrent or planned surgical procedure on the contralateral breast
研究组 & 干预措施
Standard care
Conventional post-operative care
干预措施: Dressing (Procedure)
Negative pressure therapy (NPT)
Immediate post-operative negative pressure therapy
干预措施: Negative pressure therapy (NPT) (Procedure)
结局指标
主要结局
Rate of patients experiencing postoperative wound healing complication
时间窗: From baseline to 30 days after surgery
defined as the presence of at least one of the following criteria: Deep postoperative infection of the prosthetic pocket (confirmed by a positive bacterial culture with a pathogen commonly associated with surgical site infections), wound dehiscence, or incomplete wound healing at postoperative day 30 (D30). The primary endpoint is a composite criterion (dehiscence, infection, or delayed wound healing at D30), with negative pressure wound therapy expected to reduce each complication individually. This composite endpoint capture overall postoperative wound healing complications by integrating multiple clinically relevant events into a single measure.
次要结局
- Rate of patients with a surgical site infection(From baseline to 90 days after the surgery)
- Surgical revision rate(From baseline to 90 days after the surgery)
- Incidence of patients with at least one hospital readmission(Frm baseline to 90 days after the surgery)
- Surgical complication rate according to the National Cancer Institute - Common Terminology Criteria for Adverse Events version 5 classification(Approximately 10 days, from surgery to hospital discharge)
- Time to initiation of adjuvant therapy(Approximately 3 months, from surgery to beginning of adjuvant therapy)
- Quality of life evaluated by questionnaire QLQ-C30 (Version 3)(From baseline to 15 days then to 30 and 90 days after surgery)
- Quality of life evaluated by questionnaire QLQ-BReast cancer (BR23)(From baseline to 15 days then to 30 and 90 days after surgery)
- Patient satisfaction with cosmetic result evaluated using the BR23 questionnaire(From baseline to 15 days then to 30 and 90 days after surgery)
- Medical cost of post-surgery care(From baseline to 90 days after surgery)
- Time to complete wound healing(From surgery to 30 days post-surgery)