Prevention of Postoperative Complications by Negative Pressure Therapy After Complex Breast Cancer Surgery

NCT06265558 | Recruiting

• 1 other identifier: PROICM 2023-08 TPN
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 7

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.

Conditions

Breast Cancer

Keywords

Pressure negative therapy; Breast surgery; Mastectomy

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline to 30 days after surgery

Secondary Outcomes (10)

• Rate of patients with a surgical site infection

  From baseline to 90 days after the surgery

• Surgical revision rate

  From baseline to 90 days after the surgery

• Incidence of patients with at least one hospital readmission

  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

  Approximately 10 days, from surgery to hospital discharge

• Time to initiation of adjuvant therapy

  Approximately 3 months, from surgery to beginning of adjuvant therapy

Study Arms (2)

Standard care

ACTIVE COMPARATOR

Conventional post-operative care

Procedure: Dressing

Negative pressure therapy (NPT)

EXPERIMENTAL

Immediate post-operative negative pressure therapy

Procedure: Negative pressure therapy (NPT)

Interventions

Negative pressure therapy (NPT) PROCEDURE

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.

Negative pressure therapy (NPT)

Dressing PROCEDURE

Fatty dressing or hydrocellular dressing

Standard care

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (7)

Centre Georges-François Leclerc

Dijon, Côte d'Or, 21079, France

NOT YET RECRUITING

Centre Hospitalier de Nîmes

Nîmes, GARD, 30900, France

RECRUITING

Institut Bergonié

Bordeaux, Gironde, 33076, France

NOT YET RECRUITING

Centre Hospitalier de Montpellier

Montpellier, Hérault, 34090, France

RECRUITING

Institut régional du Cancer de Montpellier

Montpellier, Hérault, 34298, France

RECRUITING

Institut de Cancérologie de l'Ouest

Angers, Maine Et Loire, 49055, France

RECRUITING

Centre Léon Bérard

Lyon, Rhône, 69373, France

NOT YET RECRUITING

Related Publications (14)

• 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.

  PMID: 27280515 BACKGROUND

• 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.

  PMID: 20140531 BACKGROUND

• 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.

  PMID: 27352202 BACKGROUND

• 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.

  PMID: 34324114 BACKGROUND

• 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.

  PMID: 24470007 BACKGROUND

• 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.

  PMID: 29464150 BACKGROUND

• 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.

  PMID: 29442143 BACKGROUND

• 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.

  PMID: 33968556 BACKGROUND

• 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.

  PMID: 31900568 BACKGROUND

• 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.

  PMID: 34060773 BACKGROUND

• 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.

  PMID: 30324063 BACKGROUND

• 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.

  PMID: 32542647 BACKGROUND

• 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.

  PMID: 33609382 BACKGROUND

• 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.

  PMID: 41485781 BACKGROUND

Related Links

• Breast cancers - Recommendations and practice aids
• French Society of Senology and Breast Pathology multimedia library

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Negative-Pressure Wound Therapy; Bandages

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques; Equipment and Supplies

Study Officials

• Mathias NERON, MD

  Institut régional du Cancer de Montpellier (ICM)

  STUDY CHAIR

Central Study Contacts

Mathias NERON, MD

CONTACT

467614813; mathias.neron@icm.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 20, 2024
• Study Start: April 15, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• 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.
• 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.

Locations

FR (7)