Prevention of Postoperative Complications by Negative Pressure Therapy After Complex Breast Cancer Surgery (TPN-SEIN)

April 3, 2024 updated by: Institut du Cancer de Montpellier - Val d'Aurelle

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

254

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Gard
      • Nîmes, Gard, France, 30900
        • Centre Hospitalier de Nîmes
        • Contact:
        • Principal Investigator:
          • Fanny BECHARD, MD
    • Hérault
      • Montpellier, Hérault, France, 34298
        • Institut Regional du Cancer de Montpellier
        • Contact:
        • Principal Investigator:
          • Mathias NERON, MD
      • Montpellier, Hérault, France, 34090
        • Centre Hospitalier de Montpellier
        • Contact:
        • Principal Investigator:
          • Martha DURAES, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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
    • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard care
Conventional post-operative care
Procedure: Dressing
Fatty dressing or hydrocolloid dressing
Experimental: Negative pressure therapy (NPT)
Immediate post-operative negative pressure therapy
Procedure: Negative pressure therapy (NPT)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of patients with post-operative scarring trouble
Time Frame: From baseline to 30 days after surgery
Number of patients with post-operative scarring trouble divided by the total number of patients operated on in the trial.
From baseline to 30 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of patients with a surgical site infection
Time Frame: From baseline to 90 days after the surgery
Number of patients with surgical site infection divided by total number of patients operated on in the trial.
From baseline to 90 days after the surgery
Surgical revision rate
Time Frame: From baseline to 90 days after the surgery
Number of patients with repeat surgery divided by the total number of patients operated on in the trial.
From baseline to 90 days after the surgery
Rate of patients with at least one rehospitalization
Time Frame: Frm baseline to 90 days after the surgery
Number of patients with at least one rehospitalization divided by total number of patients operated on in the trial.
Frm baseline to 90 days after the surgery
Surgical complication rate by Clavien-Dindo classification
Time Frame: Approximately 10 days, from surgery to hospital discharge
The Clavien-Dindo classification of surgical classifications is used throughout surgery for grading adverse events (complications) which occur as a result of surgical procedures. It includes 5 grades from grade 1 (recourse to usual postoperative treatments) to Grade 5 (death).
Approximately 10 days, from surgery to hospital discharge
Time to initiation of adjuvant therapy
Time Frame: Approximately 3 months, from surgery to beginning of adjuvant therapy
Number of days between surgery and initiation of adjuvant therapy
Approximately 3 months, from surgery to beginning of adjuvant therapy
Quality of life evaluated by questionnaire QLQ-C30 (Version 3)
Time Frame: From baseline to 15 days then to 30 and 90 days after surgery

The EORTC QLG Core Questionnaire (EORTC QLQ-C30) is a 30-item instrument designed to measure quality of life in all cancer patients.Version 3, incorporates five functional scales on physical (PF), role (RF), cognitive (CF), emotional (EF) and social (SF) functioning, three symptom scales on fatigue (FA), pain (PA) and nausea and vomiting (NV), single items assessing dyspnoea (DY), insomnia (SL), loss of appetite (AP), constipation (CO) and diarrhoea (DI), one item assessing perceived financial impact (FI) and a global health status/QoL scale (Global QoL). Each item is scored in one of four categories 1) 'Not at all', 2) 'A little', 3) 'Quite a bit' 4) 'Very much', with the exception of 'Global QoL'which ranges from 1) 'Very poor' to 7) 'Excellent'.

Scoring of the items in the PF scale in the latest revision of EORTC QLQ-C30, Version 3 is extended to the four-point scale instead of the previous 'Yes/No' dichotomy
From baseline to 15 days then to 30 and 90 days after surgery
Quality of life evaluated by questionnaire QLQ-BReast cancer (BR23)
Time Frame: From baseline to 15 days then to 30 and 90 days after surgery
The Breast Cancer module is a supplementary questionnaire module to be employed in conjunction with the QLQ-C30. The QLQ-BR23 incorporates five multi-item scales to assess body image, sexual functioning, systemic therapy side effects, breast symptoms, and arm symptoms. All of the scales and single-item measures range in score from 0 to 100. A high score for the functional scales represents a high/healthy level of functioning, whilst a high score for the symptom scales represents a high level of symptomatology or problems.
From baseline to 15 days then to 30 and 90 days after surgery
Patient satisfaction about cosmetic result evaluated using the BR23 questionnaire
Time Frame: From baseline to 15 days then to 30 and 90 days after surgery
The QLQ-BR23 incorporates five multi-item scales to assess body image, sexual functioning, systemic therapy side effects, breast symptoms, and arm symptoms.
From baseline to 15 days then to 30 and 90 days after surgery
Medical cost of post-surgery care
Time Frame: From baseline to 90 days after surgery
There will be a comparison between two arms. The medical cost of post-surgery care will be calculated on the basis of data such as number and type of dressings, consumables, time spent by the nurse, reason for hospital consultations and hospitalization, type of transport with home-hospital distance.
From baseline to 90 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

  • Study Chair: Mathias NERON, MD, Institut régional du Cancer de Montpellier (ICM)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

February 7, 2024

First Submitted That Met QC Criteria

February 16, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROICM 2023-08 TPN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Participant data will be made available on request and with the completion of a contract between the sponsor and the requester.

IPD Sharing Time Frame

Access to study data upon written detailed request sent to the institute of Montpellier Cancer (ICM), following publication and until 5 years after publication of summary data.

IPD Sharing Access Criteria

The data shared will be limited to that required for independent mandated verification of the published results, the applicant will need authorization from ICM for personal access, and data will only be transferred after signing of a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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