About this 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Negative pressure therapy (NPT)
- Dressing