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

RecruitingNAAges 18 Years - anyAllCentre Leon Berard
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In plain words

What the trial is, and whether it could suit you

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)

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥ 18 years at the day of consenting to the study * Patients with primary STS of the limb or trunk treated with preoperative external radiation therapy (decided in multidisciplinary board) * Intent to cure resection required for STS planned between 3 to 8 weeks after the end of RT * Planned primary wound closure, including local or distant jambeau * Ability to understand and willingness for follow-up visits * Covered by a medical insurance * Signed and dated informed consent document indicating that the patient has been informed of all aspects of the trial prior to enrolment. Exclusion Criteria: * Known hypersensibility to silver * Patients with a diagnosis of Ewing's sarcoma, chondrosarcoma, osteosarcoma, or desmoid tumor. Nota bene: Only patients with bone tumors are affected; patients with soft tissue tumors can be included in the study. * Patient in relapse setting; * Patient requiring a surgical revision after R1 or R2 resection; * Planned blade drainage; * Planned no wound-closure and skin graft after resection * Patient requiring authorship or curators or patient deprived of liberty.
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What it tests

  • Prevena
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Where

15 sites
CHU Nantes
Nantes, France
Centre Leon Berard
Lyon, 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

…and 7 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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