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RECRUITING
NCT06265558
NA

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

Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

View on ClinicalTrials.gov

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

PROCEDURE

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.

PROCEDURE

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