Trial Title:
Prevention of Postoperative Complications by Negative Pressure Therapy After Complex Breast Cancer Surgery
NCT ID:
NCT06265558
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Postoperative Complications
Conditions: Keywords:
Pressure negative therapy
Breast surgery
Mastectomy
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Negative pressure therapy (NPT)
Description:
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.
Arm group label:
Negative pressure therapy (NPT)
Intervention type:
Procedure
Intervention name:
Dressing
Description:
Fatty dressing or hydrocellular dressing
Arm group label:
Standard care
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.
Criteria for 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
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Georges-François Leclerc
Address:
City:
Dijon
Zip:
21079
Country:
France
Contact:
Last name:
Pierre BURNIER, MD
Email:
PBurnier@cgfl.fr
Investigator:
Last name:
Pierre BURNIER, MD
Email:
Principal Investigator
Facility:
Name:
Centre Hospitalier de Nîmes
Address:
City:
Nîmes
Zip:
30900
Country:
France
Contact:
Last name:
Fanny BECHARD, MD
Phone:
669318484
Phone ext:
+33
Email:
fanny.bechard@hotmail.fr
Investigator:
Last name:
Fanny BECHARD, MD
Email:
Principal Investigator
Facility:
Name:
Institut Bergonié
Address:
City:
Bordeaux
Zip:
33076
Country:
France
Contact:
Last name:
Hélène CHARITANSKY, MD
Email:
h.charitansky@bordeaux.unicancer.fr
Investigator:
Last name:
Hélène CHARITANSKY, MD
Email:
Principal Investigator
Facility:
Name:
Centre Hospitalier de Montpellier
Address:
City:
Montpellier
Zip:
34090
Country:
France
Contact:
Last name:
Martha DURAES, MD
Phone:
467336532
Phone ext:
+33
Email:
m-duraes@chu-montpellier.fr
Investigator:
Last name:
Martha DURAES, MD
Email:
Principal Investigator
Facility:
Name:
Institut régional du Cancer de Montpellier
Address:
City:
Montpellier
Zip:
34298
Country:
France
Contact:
Last name:
Mathias NERON, MD
Phone:
467614813
Phone ext:
+33
Email:
mathias.neron@icm.unicancer.fr
Investigator:
Last name:
Mathias NERON, MD
Email:
Principal Investigator
Facility:
Name:
Institut de Cancérologie de l'Ouest
Address:
City:
Angers
Zip:
49055
Country:
France
Contact:
Last name:
Augustin REYNARD, MD
Phone:
241352902
Phone ext:
+33
Email:
augustin.reynard@ico.unicancer.fr
Investigator:
Last name:
Augustin REYNARD, MD
Email:
Principal Investigator
Facility:
Name:
Centre Léon Bérard
Address:
City:
Lyon
Zip:
69373
Country:
France
Contact:
Last name:
Mellie HEINEMANN, MD
Phone:
478782776
Phone ext:
+33
Email:
Mellie.HEINEMANN@lyon.unicancer.fr
Investigator:
Last name:
Mellie HEINEMANN, MD
Email:
Principal Investigator
Start date:
December 2024
Completion date:
February 2027
Lead sponsor:
Agency:
Institut du Cancer de Montpellier - Val d'Aurelle
Agency class:
Other
Source:
Institut du Cancer de Montpellier - Val d'Aurelle
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06265558
https://www.e-cancer.fr/Professionnels-de-sante/Recommandations-et-outils-d-aide-a-la-pratique/Cancers-du-sein
http://medias.sfspm.org/Lyon-2021/Programme/2/Enseignements-en-Chirurgie/
