RecruitingNot ApplicableNCT05944913

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

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


Sponsor

Centre Leon Berard

Enrollment

166 participants

Start Date

Aug 3, 2023

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of wound dressings after surgery for soft tissue sarcoma (a cancer of fat, muscle, or connective tissue) in patients who received radiation before their operation. Researchers want to see if a special vacuum-assisted dressing (negative pressure wound therapy) reduces wound complications better than a standard dressing. **You may be eligible if...** - You are 18 or older - You have a soft tissue sarcoma of the limb or trunk and received radiation before surgery - You are scheduled for surgery 3–8 weeks after completing radiation, with the goal of removing all the cancer - Your wound is expected to be closed directly (primary closure) - You have medical insurance and are willing to attend follow-up visits **You may NOT be eligible if...** - You have a known allergy to silver (used in the dressings) - Your sarcoma is Ewing's sarcoma, chondrosarcoma, osteosarcoma, or desmoid tumor - Your wound cannot be closed and requires skin grafting Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPrevena

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

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NCT05944913


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