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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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)

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form document indicating that the patient has been informed of all aspects of the trial prior to enrolment. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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