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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Institut de Cancérologie de l'Ouest
RECRUITING
Angers
Institut Bergonié
NOT_YET_RECRUITING
Bordeaux
Centre Georges-François Leclerc
NOT_YET_RECRUITING
Dijon
Centre Léon Bérard
NOT_YET_RECRUITING
Lyon
Centre Hospitalier de Montpellier
RECRUITING
Montpellier
Institut régional du Cancer de Montpellier
NOT_YET_RECRUITING
Montpellier
Centre Hospitalier de Nîmes
NOT_YET_RECRUITING
Nîmes
Contact Information
Primary
Mathias NERON, MD
mathias.neron@icm.unicancer.fr
467614813
Time Frame
Start Date: 2025-04-15
Estimated Completion Date: 2027-07
Participants
Target number of participants: 254
Treatments
Active_comparator: Standard care
Conventional post-operative care
Experimental: Negative pressure therapy (NPT)
Immediate post-operative negative pressure therapy
Related Therapeutic Areas
Sponsors
Leads: Institut du Cancer de Montpellier - Val d'Aurelle

This content was sourced from clinicaltrials.gov