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

Breast Cancer

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

Inclusion Criteria13

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.
Patient presenting at least one of the following risk factors for scarring disorders:
Obesity with Body Mass Index BMI ≥ 30 and/or Cup size ≥ E
Active smoking or smoking cessation for less than one month
Diabetes
History of homolateral breast radiotherapy
Long-term corticosteroid therapy
Patient to have signed informed consent prior to study entry
Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
Patient affiliated with a health insurance plan.

Exclusion Criteria5

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
Any concurrent or planned surgical procedure on the contralateral breast

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