NCT05944913Recruiting
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
Source: ClinicalTrials.gov · Last updated 8 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 166 (estimated)
- First submitted
- 26 Jun 2023
- Start date
- 3 Aug 2023
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- Centre Leon Berard
- Diseases
- Sarcoma
- NCT number
- NCT05944913
What you commit to
- Study type: Interventional
- Planned participants: 166
- From 3 Aug 2023 to the primary completion date, 31 Aug 2026
- 15 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient requiring a surgical revision after R1 or R2 resection;
- Planned no wound-closure and skin graft after resection
Other
- 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;
- Planned blade drainage;
- Patient requiring authorship or curators or patient deprived of liberty.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut de Cancérologie de l'Ouest - Pays de Loire Coordinator of this site? Confirm its status | Angers | France | Recruiting |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| CHRU Tours - Hopital Trousseau Coordinator of this site? Confirm its status | Chambray-lès-Tours | France | Recruiting |
| Centre Jean Perrin Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Recruiting |
| Centre Georges François Leclerc Coordinator of this site? Confirm its status | Dijon | France | Recruiting |
| Centre Oscar Lambert Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| CHU Limoges Coordinator of this site? Confirm its status | Limoges | France | Recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Institut du Cancer de Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| CHU Nantes Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| APHP - Hôpital Cochin Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| Institut Curie Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| CHU Rennes Coordinator of this site? Confirm its status | Rennes | France | Not yet recruiting |
| IUCT Oncopôle Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| Institut de Cancérologie de Lorraine Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.