Breast CancerTPN-SEINNCT06265558
Prevention of Postoperative Complications by Negative Pressure Therapy After Complex Breast Cancer Surgery
A study testing Negative pressure therapy (NPT) and Dressing in people with Breast Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 7 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Negative pressure therapy (NPT) and Dressing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 7 sitesFrance
- Study dates
- 15 Apr 2025to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female ≥ 18 years
- Patient with unilateral invasive or in situ breast carcinoma
- Patient with or without neoadjuvant treatment
- Patient presenting an indication for complex breast surgery by mastectomy with immediate breast reconstruction by implant or oncoplasty by T-shaped mammoplasty.
- 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
Show all 13Show fewer
- Active smoking or smoking cessation for less than one month
- Diabetes
- History of homolateral breast radiotherapy
- Long-term corticosteroid therapy
- Patient to have signed informed consent prior to study entry
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- Patient affiliated with a health insurance plan.
Who cannot join
- Legal incapacity or limited legal capacity. Medical or psychological conditions preventing the patient from completing the study or signing the consent form.
- Pregnant or breast-feeding patient as determined in medical records as part of standard patients care and follow-up
- Patient under guardianship or safeguard of justice
- Patient participating in an interventional study with the objective of wound healing
- Any concurrent or planned surgical procedure on the contralateral breast
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites, 7 recruiting
- Recruiting
Institut de Cancérologie de l'Ouest
Angers, Maine Et Loire, 49055
Augustin REYNARD, MD, 241352902 ext. +33, augustin.reynard@ico.unicancer.fr
Augustin REYNARD, MD
- Not yet recruiting
Institut Bergonié
Bordeaux, Gironde, 33076
Hélène CHARITANSKY, MD, h.charitansky@bordeaux.unicancer.fr
Hélène CHARITANSKY, MD
- Not yet recruiting
Centre Georges-François Leclerc
Dijon, Côte d'Or, 21079
Pierre BURNIER, MD, PBurnier@cgfl.fr
Pierre BURNIER, MD
- Not yet recruiting
Centre Léon Bérard
Lyon, Rhône, 69373
Mellie HEINEMANN, MD, 478782776 ext. +33, Mellie.HEINEMANN@lyon.unicancer.fr
Mellie HEINEMANN, MD
- Recruiting
Centre Hospitalier de Montpellier
Montpellier, Hérault, 34090
Martha DURAES, MD, 467336532 ext. +33, m-duraes@chu-montpellier.fr
Martha DURAES, MD
- Recruiting
Institut régional du Cancer de Montpellier
Montpellier, Hérault, 34298
Mathias NERON, MD, 467614813 ext. +33, mathias.neron@icm.unicancer.fr
Mathias NERON, MD
- Recruiting
Centre Hospitalier de Nîmes
Nîmes, GARD, 30900
Fanny BECHARD, MD, 669318484 ext. +33, fanny.bechard@hotmail.fr
Fanny BECHARD, MD
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Negative pressure therapy (NPT), Dressing
- Keywords
- Pressure negative therapy, Breast surgery, Mastectomy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative pressure therapy (NPT)Procedure or surgery
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.
DressingProcedure or surgery
Fatty dressing or hydrocellular dressing
| Study group | Role | What they receive |
|---|---|---|
| Standard care | Active comparator | Conventional post-operative care Receives: Procedure: Dressing |
| Negative pressure therapy (NPT) | Experimental | Immediate post-operative negative pressure therapy Receives: Procedure: Negative pressure therapy (NPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients experiencing postoperative wound healing complication
defined as the presence of at least one of the following criteria: Deep postoperative infection of the prosthetic pocket (confirmed by a positive bacterial culture with a pathogen commonly associated with surgical site infections), wound dehiscence, or incomplete wound healing at postoperative day 30 (D30). The primary endpoint is a composite criterion (dehiscence, infection, or delayed wound healing at D30), with negative pressure wound therapy expected to reduce each complication individually. This composite endpoint capture overall postoperative wound healing complications by integrating multiple clinically relevant events into a single measure.
Measured: From baseline to 30 days after surgery
Secondary outcomes (10)
Rate of patients with a surgical site infection
Number of patients with surgical site infection divided by total number of patients operated on in the trial.
Measured: From baseline to 90 days after the surgery
Surgical revision rate
Number of patients with repeat surgery divided by the total number of patients operated on in the trial.
Measured: From baseline to 90 days after the surgery
Incidence of patients with at least one hospital readmission
Number of patients with at least one hospital readmission divided by total number of patients operated on in the trial.
Measured: Frm baseline to 90 days after the surgery
Surgical complication rate according to the National Cancer Institute - Common Terminology Criteria for Adverse Events version 5 classification
The NCI CTC classification is used for grading adverse events which occur as a result of trial procedures. It includes 5 grades from grade 1 (recourse to usual postoperative treatments) to Grade 5 (death).
Measured: Approximately 10 days, from surgery to hospital discharge
Time to initiation of adjuvant therapy
Number of days between surgery and initiation of adjuvant therapy
Measured: Approximately 3 months, from surgery to beginning of adjuvant therapy
Quality of life evaluated by questionnaire QLQ-C30 (Version 3)
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
Measured: From baseline to 15 days then to 30 and 90 days after surgery
Quality of life evaluated by questionnaire QLQ-BReast cancer (BR23)
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.
Measured: From baseline to 15 days then to 30 and 90 days after surgery
Patient satisfaction with cosmetic result evaluated using the BR23 questionnaire
The QLQ-BR23 incorporates five multi-item scales to assess body image, sexual functioning, systemic therapy side effects, breast symptoms, and arm symptoms.
Measured: From baseline to 15 days then to 30 and 90 days after surgery
Medical cost of post-surgery care
A comparison will be conducted between the two study arms. The cost of post-operative care will be calculated based on data including the number and type of dressings, consumables, nursing time, reasons for hospital consultations and hospitalisations, and mode of transport in relation to the distance between the patient's home and the hospital
Measured: From baseline to 90 days after surgery
Time to complete wound healing
It will be evaluated clinically by surgeon
Measured: From surgery to 30 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start15 Apr 2025
- Primary completionMay 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 254 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathias NERON, MD, Study chair, Institut régional du Cancer de Montpellier (ICM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265558
- Sponsor's protocol ID
- PROICM 2023-08 TPN
- Acronym
- TPN-SEIN
- Status last verified
- Feb 2026
- First submitted
- 7 Feb 2024
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant data will be made available on request and with the completion of a contract between the sponsor and the requester.
Publications
Bowen ME, Mone MC, Buys SS, Sheng X, Nelson EW. Surgical Outcomes for Mastectomy Patients Receiving Neoadjuvant Chemotherapy: A Propensity-Matched Analysis. Ann Surg. 2017 Mar;265(3):448-456. doi: 10.1097/SLA.0000000000001804.
PubMed 27280515Clough KB, Kaufman GJ, Nos C, Buccimazza I, Sarfati IM. Improving breast cancer surgery: a classification and quadrant per quadrant atlas for oncoplastic surgery. Ann Surg Oncol. 2010 May;17(5):1375-91. doi: 10.1245/s10434-009-0792-y. Epub 2010 Feb 6.
PubMed 20140531Donovan CA, Harit AP, Chung A, Bao J, Giuliano AE, Amersi F. Oncological and Surgical Outcomes After Nipple-Sparing Mastectomy: Do Incisions Matter? Ann Surg Oncol. 2016 Oct;23(10):3226-31. doi: 10.1245/s10434-016-5323-z. Epub 2016 Jun 28.
PubMed 27352202Bleicher RJ, Moran MS, Ruth K, Edge SB, Dietz JM, Wilke LG, Stearns V, Kurtzman SH, Klein J, Yao KA. The Impact of Radiotherapy Delay in Breast Conservation Patients Not Receiving Chemotherapy and the Rationale for Dichotomizing the Radiation Oncology Time-Dependent Standard into Two Quality Measures. Ann Surg Oncol. 2022 Jan;29(1):469-481. doi: 10.1245/s10434-021-10512-1. Epub 2021 Jul 29.
PubMed 34324114Gagliato Dde M, Gonzalez-Angulo AM, Lei X, Theriault RL, Giordano SH, Valero V, Hortobagyi GN, Chavez-Macgregor M. Clinical impact of delaying initiation of adjuvant chemotherapy in patients with breast cancer. J Clin Oncol. 2014 Mar 10;32(8):735-44. doi: 10.1200/JCO.2013.49.7693. Epub 2014 Jan 27.
PubMed 24470007Galiano RD, Hudson D, Shin J, van der Hulst R, Tanaydin V, Djohan R, Duteille F, Cockwill J, Megginson S, Huddleston E. Incisional Negative Pressure Wound Therapy for Prevention of Wound Healing Complications Following Reduction Mammaplasty. Plast Reconstr Surg Glob Open. 2018 Jan 12;6(1):e1560. doi: 10.1097/GOX.0000000000001560. eCollection 2018 Jan.
PubMed 29464150Tanaydin V, Beugels J, Andriessen A, Sawor JH, van der Hulst RRWJ. Randomized Controlled Study Comparing Disposable Negative-Pressure Wound Therapy with Standard Care in Bilateral Breast Reduction Mammoplasty Evaluating Surgical Site Complications and Scar Quality. Aesthetic Plast Surg. 2018 Aug;42(4):927-935. doi: 10.1007/s00266-018-1095-0. Epub 2018 Feb 13.
PubMed 29442143Johnson ON 3rd, Reitz CL, Thai K. Closed Incisional Negative Pressure Therapy Significantly Reduces Early Wound Dehiscence after Reduction Mammaplasty. Plast Reconstr Surg Glob Open. 2021 Mar 22;9(3):e3496. doi: 10.1097/GOX.0000000000003496. eCollection 2021 Mar.
PubMed 33968556Cagney D, Simmons L, O'Leary DP, Corrigan M, Kelly L, O'Sullivan MJ, Liew A, Redmond HP. The Efficacy of Prophylactic Negative Pressure Wound Therapy for Closed Incisions in Breast Surgery: A Systematic Review and Meta-Analysis. World J Surg. 2020 May;44(5):1526-1537. doi: 10.1007/s00268-019-05335-x.
PubMed 31900568Chicco M, Huang TC, Cheng HT. Negative-Pressure Wound Therapy in the Prevention and Management of Complications From Prosthetic Breast Reconstruction: A Systematic Review and Meta-analysis. Ann Plast Surg. 2021 Oct 1;87(4):478-483. doi: 10.1097/SAP.0000000000002722.
PubMed 34060773Gabriel A, Sigalove S, Sigalove N, Storm-Dickerson T, Rice J, Maxwell P, Griffin L. The Impact of Closed Incision Negative Pressure Therapy on Postoperative Breast Reconstruction Outcomes. Plast Reconstr Surg Glob Open. 2018 Aug 7;6(8):e1880. doi: 10.1097/GOX.0000000000001880. eCollection 2018 Aug.
PubMed 30324063Norman G, Goh EL, Dumville JC, Shi C, Liu Z, Chiverton L, Stankiewicz M, Reid A. Negative pressure wound therapy for surgical wounds healing by primary closure. Cochrane Database Syst Rev. 2020 Jun 15;6(6):CD009261. doi: 10.1002/14651858.CD009261.pub6.
PubMed 32542647Saunders C, Nherera LM, Horner A, Trueman P. Single-use negative-pressure wound therapy versus conventional dressings for closed surgical incisions: systematic literature review and meta-analysis. BJS Open. 2021 Jan 8;5(1):zraa003. doi: 10.1093/bjsopen/zraa003.
PubMed 33609382Neron M, Delmond L, Gourgou S, Delaine S, Chalbos P, Moussion A, Taoum C. Prevention of postoperative complications with negative pressure wound therapy after complex breast cancer surgery: a study protocol of a randomised controlled trial (TPN-SEIN). BMJ Open. 2026 Jan 3;16(1):e103827. doi: 10.1136/bmjopen-2025-103827.
PubMed 41485781
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Postoperative Complications by Negative Pressure Therapy After Complex Breast Cancer Surgery: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06265558
- Acronym / sponsor ID
- TPN-SEIN / PROICM 2023-08 TPN
- Conditions
- Breast Cancer
- Keywords
- Pressure negative therapy, Breast surgery, Mastectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 254 participants (estimated)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | Active comparator | Procedure: DressingConventional post-operative care |
| Negative pressure therapy (NPT) | Experimental | Procedure: Negative pressure therapy (NPT)Immediate post-operative negative pressure therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Female ≥ 18 years
- Patient with unilateral invasive or in situ breast carcinoma
- Patient with or without neoadjuvant treatment
- Patient presenting an indication for complex breast surgery by mastectomy with immediate breast reconstruction by implant or oncoplasty by T-shaped mammoplasty.
- Patient presenting at least one of the following risk factors for scarring disorders:
Key exclusion criteria (5 listed)
- Legal incapacity or limited legal capacity. Medical or psychological conditions preventing the patient from completing the study or signing the consent form.
- Pregnant or breast-feeding patient as determined in medical records as part of standard patients care and follow-up
- Patient under guardianship or safeguard of justice
- Patient participating in an interventional study with the objective of wound healing
- Any concurrent or planned surgical procedure on the contralateral breast
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Negative pressure therapy (NPT) |
| DressingFatty dressing or hydrocellular dressing | Procedure or surgery | Standard care |
Primary outcome
Rate of patients experiencing postoperative wound healing complication
Time frame: From baseline to 30 days after surgery
defined as the presence of at least one of the following criteria: Deep postoperative infection of the prosthetic pocket (confirmed by a positive bacterial culture with a pathogen commonly associated with surgical site infections), wound dehiscence, or incomplete wound healing at postoperative day 30 (D30). The primary endpoint is a composite criterion (dehiscence, infection, or delayed wound healing at D30), with negative pressure wound therapy expected to reduce each complication individually. This composite endpoint capture overall postoperative wound healing complications by integrating multiple clinically relevant events into a single measure.
10 secondary outcomes
Rate of patients with a surgical site infection
Time frame: From baseline to 90 days after the surgery
Surgical revision rate
Time frame: From baseline to 90 days after the surgery
Incidence of patients with at least one hospital readmission
Time frame: Frm baseline to 90 days after the surgery
Surgical complication rate according to the National Cancer Institute - Common Terminology Criteria for Adverse Events version 5 classification
Time frame: 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
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
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
Patient satisfaction with cosmetic result evaluated using the BR23 questionnaire
Time frame: 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
Time to complete wound healing
Time frame: From surgery to 30 days post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Background: PubMed 27280515Bowen ME, Mone MC, Buys SS, Sheng X, Nelson EW. Surgical Outcomes for Mastectomy Patients Receiving Neoadjuvant Chemotherapy: A Propensity-Matched Analysis. Ann Surg. 2017 Mar;265(3):448-456. doi: 10.1097/SLA.0000000000001804.
- Background: PubMed 20140531Clough KB, Kaufman GJ, Nos C, Buccimazza I, Sarfati IM. Improving breast cancer surgery: a classification and quadrant per quadrant atlas for oncoplastic surgery. Ann Surg Oncol. 2010 May;17(5):1375-91. doi: 10.1245/s10434-009-0792-y. Epub 2010 Feb 6.
- Background: PubMed 27352202Donovan CA, Harit AP, Chung A, Bao J, Giuliano AE, Amersi F. Oncological and Surgical Outcomes After Nipple-Sparing Mastectomy: Do Incisions Matter? Ann Surg Oncol. 2016 Oct;23(10):3226-31. doi: 10.1245/s10434-016-5323-z. Epub 2016 Jun 28.
- Background: PubMed 34324114Bleicher RJ, Moran MS, Ruth K, Edge SB, Dietz JM, Wilke LG, Stearns V, Kurtzman SH, Klein J, Yao KA. The Impact of Radiotherapy Delay in Breast Conservation Patients Not Receiving Chemotherapy and the Rationale for Dichotomizing the Radiation Oncology Time-Dependent Standard into Two Quality Measures. Ann Surg Oncol. 2022 Jan;29(1):469-481. doi: 10.1245/s10434-021-10512-1. Epub 2021 Jul 29.
- Background: PubMed 24470007Gagliato Dde M, Gonzalez-Angulo AM, Lei X, Theriault RL, Giordano SH, Valero V, Hortobagyi GN, Chavez-Macgregor M. Clinical impact of delaying initiation of adjuvant chemotherapy in patients with breast cancer. J Clin Oncol. 2014 Mar 10;32(8):735-44. doi: 10.1200/JCO.2013.49.7693. Epub 2014 Jan 27.
- Background: PubMed 29464150Galiano RD, Hudson D, Shin J, van der Hulst R, Tanaydin V, Djohan R, Duteille F, Cockwill J, Megginson S, Huddleston E. Incisional Negative Pressure Wound Therapy for Prevention of Wound Healing Complications Following Reduction Mammaplasty. Plast Reconstr Surg Glob Open. 2018 Jan 12;6(1):e1560. doi: 10.1097/GOX.0000000000001560. eCollection 2018 Jan.
- Background: PubMed 29442143Tanaydin V, Beugels J, Andriessen A, Sawor JH, van der Hulst RRWJ. Randomized Controlled Study Comparing Disposable Negative-Pressure Wound Therapy with Standard Care in Bilateral Breast Reduction Mammoplasty Evaluating Surgical Site Complications and Scar Quality. Aesthetic Plast Surg. 2018 Aug;42(4):927-935. doi: 10.1007/s00266-018-1095-0. Epub 2018 Feb 13.
- Background: PubMed 33968556Johnson ON 3rd, Reitz CL, Thai K. Closed Incisional Negative Pressure Therapy Significantly Reduces Early Wound Dehiscence after Reduction Mammaplasty. Plast Reconstr Surg Glob Open. 2021 Mar 22;9(3):e3496. doi: 10.1097/GOX.0000000000003496. eCollection 2021 Mar.
- Background: PubMed 31900568Cagney D, Simmons L, O'Leary DP, Corrigan M, Kelly L, O'Sullivan MJ, Liew A, Redmond HP. The Efficacy of Prophylactic Negative Pressure Wound Therapy for Closed Incisions in Breast Surgery: A Systematic Review and Meta-Analysis. World J Surg. 2020 May;44(5):1526-1537. doi: 10.1007/s00268-019-05335-x.
- Background: PubMed 34060773Chicco M, Huang TC, Cheng HT. Negative-Pressure Wound Therapy in the Prevention and Management of Complications From Prosthetic Breast Reconstruction: A Systematic Review and Meta-analysis. Ann Plast Surg. 2021 Oct 1;87(4):478-483. doi: 10.1097/SAP.0000000000002722.
- Background: PubMed 30324063Gabriel A, Sigalove S, Sigalove N, Storm-Dickerson T, Rice J, Maxwell P, Griffin L. The Impact of Closed Incision Negative Pressure Therapy on Postoperative Breast Reconstruction Outcomes. Plast Reconstr Surg Glob Open. 2018 Aug 7;6(8):e1880. doi: 10.1097/GOX.0000000000001880. eCollection 2018 Aug.
- Background: PubMed 32542647Norman G, Goh EL, Dumville JC, Shi C, Liu Z, Chiverton L, Stankiewicz M, Reid A. Negative pressure wound therapy for surgical wounds healing by primary closure. Cochrane Database Syst Rev. 2020 Jun 15;6(6):CD009261. doi: 10.1002/14651858.CD009261.pub6.
- Breast cancers - Recommendations and practice aidsLink provided by the sponsor.
- French Society of Senology and Breast Pathology multimedia libraryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Participant data will be made available on request and with the completion of a contract between the sponsor and the requester.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mathias NERON, MD study chair
Institut régional du Cancer de Montpellier (ICM)
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative pressure therapy (NPT) and Dressing in people with Breast Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mathias NERON, MD (467614813 ext. +33, mathias.neron@icm.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients experiencing postoperative wound healing complication (time frame: From baseline to 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06265558, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.