Prevention of Postoperative Complications by Negative Pressure Therapy After Complex Breast Cancer Surgery

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorInstitut du Cancer de Montpellier - Val d'Aurelle

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

Treatment groups

254 Participants
are divided into 2 treatment groups