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RECRUITING
NCT05944913
NA

Study Comparing Negative Pressure Dressing vs Conventional in Patients With Resected STS After Radiotherapy

Sponsor: Centre Leon Berard

View on ClinicalTrials.gov

Summary

This is a randomized (1:1 ratio), prospective, comparative, controlled, open-label study. The aim is to compare the efficacy of negative pressure therapy (PREVENA™) versus standard postoperative wound management on the wound healing after surgery for previously irradiated Soft Tissue Sarcoma (STS)

Official title: Randomized Study Comparing Negative Pressure Dressing Versus Conventional Dressing in Patients With Resected Limb or Trunk Soft Tissue Sarcoma (STS) After External Radiotherapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

166

Start Date

2023-08-03

Completion Date

2026-11

Last Updated

2025-08-08

Healthy Volunteers

No

Interventions

DEVICE

Prevena

PREVENA™ is a CE-marked class IIa medical device. The PREVENA™ Incision Management System is also intended to manage the environment of closed surgical incisions and surround intact skin in patients at risk for developing post-operative complications, such as infection, by maintaining a closed environment via the application of a negative pressure wound therapy system to the incision.

Locations (15)

CHU Nantes

Nantes, Pays de Loire, France

Centre Leon Berard

Lyon, Rhône-Alpes Auvergne, France

Institut de Cancérologie de l'Ouest - Pays de Loire

Angers, France

Institut Bergonié

Bordeaux, France

CHRU Tours Hôpital Trousseau

Chambray-lès-Tours, France

Centre Jean Perrin

Clermont-Ferrand, France

Centre Georges François Leclerc

Dijon, France

Centre Oscar Lambert

Lille, France

CHU Limoges

Limoges, France

Institut du Cancer de Montpellier

Montpellier, France

Institut Curie

Paris, France

APHP Hôpital Cochin

Paris, France

CHU Rennes

Rennes, France

IUCT Oncopole

Toulouse, France

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, France