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

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

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.

Conditions2

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