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Prevention of Postoperative Complications by Negative Pressure Therapy After Complex Breast Cancer Surgery
Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Summary
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.
Official title: Prevention of Postoperative Complications by Negative Pressure Therapy After Complex Breast Cancer Surgery: a Prospective Randomized Controlled Trial
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
254
Start Date
2025-04-15
Completion Date
2027-07
Last Updated
2026-02-05
Healthy Volunteers
No
Conditions
Interventions
Negative pressure therapy (NPT)
Negative 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
Fatty dressing or hydrocellular dressing
Locations (7)
Centre Georges-François Leclerc
Dijon, Côte d'Or, France
Centre Hospitalier de Nîmes
Nîmes, GARD, France
Institut Bergonié
Bordeaux, Gironde, France
Centre Hospitalier de Montpellier
Montpellier, Hérault, France
Institut régional du Cancer de Montpellier
Montpellier, Hérault, France
Institut de Cancérologie de l'Ouest
Angers, Maine Et Loire, France
Centre Léon Bérard
Lyon, Rhône, France