Clinical trial NCT06265558: Prevention of Postoperative Complications by Negative Pressure Therapy After Complex Breast Cancer Surgery
Official title: Prevention of Postoperative Complications by Negative Pressure Therapy After Complex Breast Cancer Surgery: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Pressure negative therapy
Breast surgery
Mastectomy
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 254
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: In 2022, excisional surgery is still one of the mainstays of breast cancer treatment. The excisional surgery is often combined with adjuvant treatments, which may include medical treatments such as chemotherapy, targeted therapies and immunotherapy, hormone therapy and radiotherapy. All these treatments have toxicities that impact on patients' quality of life.

One of the main complications of surgery is scarring. The rate is around 2% for "simple" breast surgery (conservative breast surgery - total mastectomy). This rate can rise sharply in the case of "complex" breast surgery, such as high-level oncoplasty, or mastectomy with Immediate Breast Reconstruction (IBR). This rate of surgical wound complications (ischemia, necrosis, dehiscence, infection) reached 20% in our local series of Immediate Breast Reconstruction (IBR) by prosthesis. This rate may exceed 30% in some series, depending on the surgical technique and the population, in cases of smoking, diabetes, previous radiotherapy, obesity and large breast volume. The increasing prevalence of these risk factors in the population means that scarring disorders must be taken into account in daily cancer care.

The impact of these scarring disorders is manifold:

* Delayed initiation of adjuvant therapy with an impact on overall survival.
* Cosmetic impact of scarring
* Possible loss of prosthetic breast reconstruction
* Patient dissatisfaction, with increased burden of care
* Overall impact on patient quality of life
* Economic impact linked to the length of care over time (consumption of dressing materials and personal time) Preventing the onset of wound-healing disorders is therefore vital in order to avoid these multiple consequences for the patient and the healthcare system.

In breast surgery, the use of preventive NPT (Negative Pressure Therapy) has been little studied. The NPT has been used mainly in cosmetic surgery procedures such as breast reduction, with results in favor of NPT. The most comprehensive study is a multicenter randomized trial which included 200 patients scheduled for bilateral breast reduction. In this trial, the comparison was made between the 2 breasts, each patient being her own control. The calculation of the number of subjects was based on a reduction in the complication rate from 20% to 10% (i.e., a 50% reduction). The study was positive, showing a reduction in the dehiscence rate at day 21 from 26% to 16%. In this study, patients were under-selected, and around 40% had risk factors for complications. A second randomized study, with similar methodology and judgment criteria, included 32 patients undergoing bilateral breast reduction. The results of this study are significant, but unfortunately there weren't much detail in the publication.

There is little scientific data concerning the use of negative pressure therapy after immediate breast reconstruction. There are very few data on the use of Negative pressure Therapy (NPT) after immediate Breast Reconstruction (IBR), a treatment-reconstruction strategy that has been expanding rapidly since recent years. The current literature reports only 3 studies on the use of preventive Negative pressure Therapy (NPT) in oncologic breast surgery. All three are retrospective, case-control studies with serious limitations. The largest published series involved 356 patients and 665 breasts. A reduction was reported in the overall complication rate from 15.9% to 8.5%, and a significant reduction in several criteria: infection, seroma, scar dehiscence and necrosis. However, the study presents significant biases, with non-comparable populations in terms of co-morbidities, 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 (NPT) in oncological breast surgery.

Our hypothesis, then, is that preventive NPT in the immediate post-operative phase of complex breast surgery can prevent the onset of post-operative scarring disorders and shorten the time to complete healing.

To date, there are no randomized prospective studies of NPT in complex oncologic breast surgery. Randomized studies already published in general surgery provide a good level of evidence for the efficacy of NPT in preventing local post-operative complications. The latest systematic review and meta-analysis found a reduction in the risk of surgical site infection, from 13% to 8.8%, all types of surgery included. The benefit on the risk of dehiscence in general surgery is less strong, but a 30% reduction was found in a meta-analysis of studies involving only a preventive NPT device, a device widely used throughout the world.

In view of these results from randomized trials in general surgery and non-oncological breast surgery, and the results of retrospective studies in oncological breast surgery, a randomized trial must be carried out. This randomized controlled trial will be pragmatic, incorporating an intermediate analysis, given the endpoint evaluating the reduction in complications in a surgical context, to rapidly meet our objectives with a sufficient level of evidence to have an immediate impact on patients and modify practice.

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
3. Patient under guardianship or safeguard of justice
4. Patient participating in an interventional study with the objective of wound healing

Primary outcomes:
measure: Rate of patients with post-operative scarring trouble
timeFrame: From baseline to 30 days after surgery
Secondary outcomes:
measure: Rate of patients with a surgical site infection
timeFrame: From baseline to 90 days after the surgery
measure: Surgical revision rate
timeFrame: From baseline to 90 days after the surgery
measure: Rate of patients with at least one rehospitalization
timeFrame: Frm baseline to 90 days after the surgery
measure: Surgical complication rate by Clavien-Dindo classification
timeFrame: Approximately 10 days, from surgery to hospital discharge
measure: Time to initiation of adjuvant therapy
timeFrame: Approximately 3 months, from surgery to beginning of adjuvant therapy
measure: Quality of life evaluated by questionnaire QLQ-C30 (Version 3)
timeFrame: From baseline to 15 days then to 30 and 90 days after surgery
measure: Quality of life evaluated by questionnaire QLQ-BReast cancer (BR23)
timeFrame: From baseline to 15 days then to 30 and 90 days after surgery
measure: Patient satisfaction about cosmetic result evaluated using the BR23 questionnaire
timeFrame: From baseline to 15 days then to 30 and 90 days after surgery
measure: Medical cost of post-surgery care
timeFrame: From baseline to 90 days after surgery
Other outcomes:
Locations:
city: Dijon
country: France
facility: Centre Georges-François Leclerc
state: Côte d'Or
city: Nîmes
country: France
facility: Centre Hospitalier de Nîmes
state: Gard
city: Bordeaux
country: France
facility: Institut Bergonié
state: Gironde
city: Montpellier
country: France
facility: Centre Hospitalier de Montpellier
state: Hérault
city: Montpellier
country: France
facility: Institut régional du Cancer de Montpellier
state: Hérault
city: Angers
country: France
facility: Institut de Cancérologie de l'Ouest
state: Maine Et Loire
city: Lyon
country: France
facility: Centre Léon Bérard
state: Rhône
Study officials:
affiliation: Institut régional du Cancer de Montpellier (ICM)
name: Mathias NERON, MD
role: STUDY_CHAIR
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