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Study Comparing Negative Pressure Dressing vs Conventional in Patients With Resected STS After Radiotherapy
Sponsor: Centre Leon Berard
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
Conditions
Interventions
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