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

Study acronym: TPN-SEIN
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Publications: details revised at 1 of 14 entriesv11
  2. Notable Primary endpoint revised
    • Eligibility criteria expanded, about 23 words
    • Secondary endpoints: 9 to 10
    v10
  3. Minor Site details revised at 2 of 7 sitesv9
  4. Notable Trial status: Not Yet Recruiting to Recruitingv8 Show 4 more changesShow less
    • Primary completion date: Sep 2027 to May 2027
    • Study completion date: Sep 2027 to Jul 2027
    • Start date changed from estimate of Mar 2025 to Apr 15, 2025
    • Site details revised at 7 of 7 sites
  5. Minor Start date: Feb 2025 to Mar 2025v7
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  1. Notable Primary and study completion dates: Feb 2027 to Sep 2027
    • Start date: Dec 2024 to Feb 2025
    v6
  2. Notable Start date: Sep 2024 to Dec 2024
    • Study sites: 3 to 7
    • Eligibility criteria expanded, about 1 word
    v5
  3. Notable Start date: Jun 2024 to Sep 2024v4
  4. Minor Eligibility criteria expanded, about 12 wordsv3
  5. Minor Enrollment target: 256 to 254
    • Secondary endpoints revised (9)
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06265558
Lead Sponsor Institut du Cancer de Montpellier - Val d'Aurelle
Conditions
(from sponsor)
Breast Cancer
Related terms Breast Neoplasms
Enrollment 254 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov