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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Centre Hospitalier de Nîmes
  Nîmes, Gard, France 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 Georges-François Leclerc
  Dijon, Côte d'Or, France Not yet recruiting
• Institut Bergonié
  Bordeaux, Gironde, France Not yet recruiting

Study contacts

• Study coordinator: Mathias NERON, MD
• Email: mathias.neron@icm.unicancer.fr
• Phone: 467614813

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.