protocolSection identificationModule nctId: NCT06265558, orgStudyIdInfo id: PROICM 2023-08 TPN, briefTitle: Prevention of Postoperative Complications by Negative Pressure Therapy After Complex Breast Cancer Surgery, acronym: TPN-SEIN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2027-02, completionDateStruct date: 2027-02, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Institut du Cancer de Montpellier - Val d'Aurelle, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 254, type: ESTIMATED, armsInterventionsModule interventions name: Negative pressure therapy (NPT), interventions name: Dressing, outcomesModule primaryOutcomes measure: Rate of patients with post-operative scarring trouble, secondaryOutcomes measure: Rate of patients with a surgical site infection, secondaryOutcomes measure: Surgical revision rate, secondaryOutcomes measure: Rate of patients with at least one rehospitalization, secondaryOutcomes measure: Surgical complication rate by Clavien-Dindo classification, secondaryOutcomes measure: Time to initiation of adjuvant therapy, secondaryOutcomes measure: Quality of life evaluated by questionnaire QLQ-C30 (Version 3), secondaryOutcomes measure: Quality of life evaluated by questionnaire QLQ-BReast cancer (BR23), secondaryOutcomes measure: Patient satisfaction about cosmetic result evaluated using the BR23 questionnaire, secondaryOutcomes measure: Medical cost of post-surgery care, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre Hospitalier de Nîmes, city: Nîmes, state: Gard, zip: 30900, country: France, contacts name: Fanny BECHARD, MD, role: CONTACT, email: fanny.bechard@hotmail.fr, contacts name: Fanny BECHARD, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.83333, lon: 4.35, locations facility: Centre Hospitalier de Montpellier, city: Montpellier, state: Hérault, zip: 34090, country: France, contacts name: Martha DURAES, MD, role: CONTACT, email: m-duraes@chu-montpellier.fr, contacts name: Martha DURAES, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.61092, lon: 3.87723, locations facility: Institut régional du Cancer de Montpellier, city: Montpellier, state: Hérault, zip: 34298, country: France, contacts name: Mathias NERON, MD, role: CONTACT, phone: 467614813, phoneExt: +33, email: mathias.neron@icm.unicancer.fr, contacts name: Mathias NERON, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.61092, lon: 3.87723, hasResults: False