Prevention of Postoperative Complications by Negative Pressure Therapy After Complex Breast Cancer Surgery
NCT ID: NCT06265558
Last Updated: 2026-02-05
Study Results
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Basic Information
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RECRUITING
NA
254 participants
INTERVENTIONAL
2025-04-15
2027-07-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Standard care
Conventional post-operative care
Dressing
Fatty dressing or hydrocellular dressing
Negative pressure therapy (NPT)
Immediate post-operative negative pressure therapy
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.
Interventions
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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.
Dressing
Fatty dressing or hydrocellular dressing
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
FEMALE
No
Sponsors
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Institut du Cancer de Montpellier - Val d'Aurelle
OTHER
Responsible Party
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Principal Investigators
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Mathias NERON, MD
Role: STUDY_CHAIR
Institut régional du Cancer de Montpellier (ICM)
Locations
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Centre Georges-François Leclerc
Dijon, Côte d'Or, France
Centre Hospitalier de Nîmes
Nîmes, GARD, France
Institut Bergonié
Bordeaux, Gironde, France
Centre Hospitalier de Montpellier
Montpellier, Hérault, France
Institut régional du Cancer de Montpellier
Montpellier, Hérault, France
Institut de Cancérologie de l'Ouest
Angers, Maine Et Loire, France
Centre Léon Bérard
Lyon, Rhône, France
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Clough 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.
Donovan 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.
Bleicher 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.
Gagliato 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.
Galiano 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.
Tanaydin 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.
Johnson 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.
Cagney 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.
Chicco 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.
Gabriel 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.
Norman 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.
Saunders 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.
Neron 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.
Related Links
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Breast cancers - Recommendations and practice aids
French Society of Senology and Breast Pathology multimedia library
Other Identifiers
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PROICM 2023-08 TPN
Identifier Type: -
Identifier Source: org_study_id
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