Prevention of Postoperative Complications by Negative Pressure Therapy After Complex Breast Cancer Surgery: a Prospective Randomized Controlled Trial
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.
• 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
⁃ Diabetes
⁃ 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.