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.
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
Parallel
Negative pressure therapy (NPT)
Procedure/SurgeryNegative pressure therapy (NPT) involves placing the surface of a wound under a pressure lower than the ambient atmospheric pressure. To achieve this, a specially designed dressing is connected to a vacuum source and an exudate collection system.
Dressing
Procedure/SurgeryFatty dressing or hydrocellular dressing
Rate of patients experiencing postoperative wound healing complication
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.
Rate of patients with a surgical site infection
Number of patients with surgical site infection divided by total number of patients operated on in the trial.
Surgical revision rate
Number of patients with repeat surgery divided by the total number of patients operated on in the trial.
Incidence of patients with at least one hospital readmission
Number of patients with at least one hospital readmission divided by total number of patients operated on in the trial.
Surgical complication rate according to the National Cancer Institute - Common Terminology Criteria for Adverse Events version 5 classification
The NCI CTC classification is used for grading adverse events which occur as a result of trial procedures. It includes 5 grades from grade 1 (recourse to usual postoperative treatments) to Grade 5 (death).
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