Actively Recruiting
Prevention of Postoperative Complications by Negative Pressure Therapy After Complex Breast Cancer Surgery
Led by Institut du Cancer de Montpellier - Val d'Aurelle · Updated on 2026-02-05
254
Participants Needed
7
Research Sites
115 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prevention of Postoperative Complications by Negative Pressure Therapy After Complex Breast Cancer Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 years or older
- Diagnosed with unilateral invasive or in situ breast carcinoma
- May have received or not received neoadjuvant treatment
- Scheduled for complex breast surgery by mastectomy with immediate implant reconstruction or T-shaped mammoplasty oncoplasty
- Has at least one risk factor for scarring disorders such as obesity (BMI 60; 30), cup size 60; E, active smoking or smoking cessation less than one month ago, diabetes, history of radiation on the same breast, or long-term corticosteroid therapy
- Signed informed consent before joining the study
- Willing and able to follow scheduled visits, treatment, lab tests, and other study procedures
- Affiliated with a health insurance plan
You will not qualify if you...
- Has legal incapacity or limited legal capacity or medical/psychological conditions preventing study completion or consent
- Pregnant or breastfeeding
- Under guardianship or legal protection
- Participating in another interventional wound healing study
- Has or plans any surgery on the opposite breast
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Centre Georges-François Leclerc
Dijon, Côte d'Or, France, 21079
Not Yet Recruiting
2
Centre Hospitalier de Nîmes
Nîmes, GARD, France, 30900
Actively Recruiting
3
Institut Bergonié
Bordeaux, Gironde, France, 33076
Not Yet Recruiting
4
Centre Hospitalier de Montpellier
Montpellier, Hérault, France, 34090
Actively Recruiting
5
Institut régional du Cancer de Montpellier
Montpellier, Hérault, France, 34298
Actively Recruiting
6
Institut de Cancérologie de l'Ouest
Angers, Maine Et Loire, France, 49055
Actively Recruiting
7
Centre Léon Bérard
Lyon, Rhône, France, 69373
Not Yet Recruiting
Research Team
M
Mathias NERON, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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