Using negative pressure therapy to prevent complications after complex breast cancer surgery

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

This study is testing if negative pressure therapy can help women recover better and avoid complications after complex breast cancer surgeries.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 254 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 7 sites (Dijon, Côte d'Or and 6 other locations)
• Trial ID: NCT06265558 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of negative pressure therapy (NPT) in reducing postoperative complications following complex breast cancer surgeries, such as mastectomy with immediate breast reconstruction. The study aims to address the high rates of surgical wound complications, which can significantly impact patient recovery and quality of life. By enrolling female patients with specific risk factors for scarring disorders, the trial will assess the outcomes of NPT compared to standard care. The methodology includes monitoring complication rates and patient satisfaction post-surgery.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 18 and older with unilateral invasive or in situ breast carcinoma who are undergoing complex breast surgery and have at least one risk factor for scarring disorders.

Not a fit: Patients who do not have any of the specified risk factors for scarring disorders or those with legal incapacity may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce postoperative complications and improve recovery for breast cancer patients undergoing complex surgeries.

How similar studies have performed: While there have been a few retrospective studies on negative pressure therapy in breast surgery, this trial aims to provide more robust evidence through a prospective approach.

Eligibility criteria

Inclusion Criteria:

1. Female ≥ 18 years
2. Patient with unilateral invasive or in situ breast carcinoma
3. Patient with or without neoadjuvant treatment
4. Patient presenting an indication for complex breast surgery by mastectomy with immediate breast reconstruction by implant or oncoplasty by T-shaped mammoplasty.
5. 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
6. Patient to have signed informed consent prior to study entry
7. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
8. Patient affiliated with a health insurance plan.

Exclusion Criteria:

1. Legal incapacity or limited legal capacity. Medical or psychological conditions preventing the patient from completing the study or signing the consent form.
2. Pregnant or breast-feeding patient as determined in medical records as part of standard patients care and follow-up
3. Patient under guardianship or safeguard of justice
4. Patient participating in an interventional study with the objective of wound healing
5. Any concurrent or planned surgical procedure on the contralateral breast

Where this trial is running

Dijon, Côte d'Or and 6 other locations

• Centre Georges-François Leclerc — Dijon, Côte d'Or, France (NOT_YET_RECRUITING)
• Centre Hospitalier de Nîmes — Nîmes, GARD, France (RECRUITING)
• Institut Bergonié — Bordeaux, Gironde, France (NOT_YET_RECRUITING)
• Centre Hospitalier de Montpellier — Montpellier, Hérault, France (RECRUITING)
• Institut régional du Cancer de Montpellier — Montpellier, Hérault, France (RECRUITING)
• Institut de Cancérologie de l'Ouest — Angers, Maine Et Loire, France (RECRUITING)
• Centre Léon Bérard — Lyon, Rhône, France (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Mathias NERON, MD

Conditions: Breast Cancer, Pressure negative therapy, Breast surgery, Mastectomy