Comparing negative pressure dressing to standard dressing for healing after soft tissue sarcoma surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study is a randomized, controlled trial that aims to evaluate the effectiveness of negative pressure wound therapy (PREVENA™) compared to conventional postoperative wound management in patients who have undergone surgery for soft tissue sarcoma (STS) after receiving preoperative radiation therapy. The research focuses on reducing postoperative complications associated with surgical resection of STS, which can be exacerbated by prior radiation treatment. By comparing these two approaches, the study seeks to determine if negative pressure therapy can improve wound healing outcomes without increasing the risk of local recurrence. Participants will be monitored for wound complications and overall recovery.

Why it matters

Who can join: the full rules

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.

Where it's running

• CHU Nantes
  Nantes, Pays de Loire, France Recruiting
• Centre Leon Berard
  Lyon, Rhône-Alpes Auvergne, France Recruiting
• Institut de Cancérologie de l'Ouest - Pays de Loire
  Angers, France Recruiting
• Institut Bergonié
  Bordeaux, France Recruiting
• CHRU Tours Hôpital Trousseau
  Chambray-lès-Tours, France Recruiting
• Centre Jean Perrin
  Clermont-Ferrand, France Recruiting

Study contacts

• Principal investigator: François Gouin, MD, Chirurgien — Centre Leon Berard
• Study coordinator: François Gouin, MD, Chirurgien
• Email: Francois.GOUIN@lyon.unicancer.fr
• Phone: 0469855311

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.