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

NCT06265558 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2026-02-05

No results posted yet for this study

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

Interventions

PROCEDURE

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

Dressing

Fatty dressing or hydrocellular dressing

Sponsors & Collaborators

  • Institut du Cancer de Montpellier - Val d'Aurelle

    lead OTHER

Principal Investigators

  • Mathias NERON, MD · Institut régional du Cancer de Montpellier (ICM)

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-15
Primary Completion
2027-05-31
Completion
2027-07-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06265558 on ClinicalTrials.gov