RecruitingNot ApplicableNCT06265558

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

Prevention of Postoperative Complications by Negative Pressure Therapy After Complex Breast Cancer Surgery: a Prospective Randomized Controlled Trial


Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Enrollment

254 participants

Start Date

Apr 15, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether applying a negative pressure wound therapy device (a gentle suction bandage) over the surgical incision after breast cancer surgery can reduce wound complications, particularly in patients at higher risk for poor healing. **You may be eligible if...** - You are a woman, 18 or older - You have been diagnosed with invasive or non-invasive breast cancer in one breast - You are scheduled for mastectomy with immediate reconstruction (breast implant) or a specific type of breast-conserving surgery - You have at least one healing risk factor: obesity (BMI ≥30 or large cup size), active smoking, diabetes, prior radiation to the same breast, or long-term steroid use **You may NOT be eligible if...** - You are having bilateral (both breasts) surgery - You do not have any of the listed risk factors for wound complications - You are unable to attend follow-up visits or comply with study procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURENegative 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.

PROCEDUREDressing

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

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NCT06265558


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