Tests a suction wound dressing after surgery for soft tissue sarcoma
Tests a suction dressing on wounds in adults with soft tissue sarcoma.
Plain-language title generated from the registry record
Registry title: Study Comparing Negative Pressure Dressing vs Conventional in Patients With Resected STS After Radiotherapy
Key facts
- Where
- Angers, Bordeaux, Chambray-lès-Tours, Clermont-Ferrand, Dijon, Lille, Limoges, Lyon, Montpellier, Nantes, Paris, Rennes, Toulouse, and Vandœuvre-lès-Nancy, FranceSee the 15 sites
Where in France
- Institut de Cancérologie de l'Ouest - Pays de LoireAngers, FranceTaking people
- Institut BergonieBordeaux, FranceTaking people
- CHRU Tours - Hopital TrousseauChambray-lès-Tours, FranceTaking people
- Centre Jean PerrinClermont-Ferrand, FranceTaking people
- Centre Georges François LeclercDijon, FranceTaking people
- Centre Oscar LambertLille, FranceTaking people
- CHU LimogesLimoges, FranceTaking people
- Centre Leon BerardLyon, FranceTaking people
- Institut du Cancer de MontpellierMontpellier, FranceTaking people
- CHU NantesNantes, FranceTaking people
- APHP - Hôpital CochinParis, FranceNot yet recruiting
- Institut CurieParis, FranceNot yet recruiting
- CHU RennesRennes, FranceNot yet recruiting
- IUCT OncopôleToulouse, FranceTaking people
- Institut de Cancérologie de LorraineVandœuvre-lès-Nancy, FranceNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centre Leon Berard
- Trial code
- NCT05944913
- Record updated
- 8 August 2025
- Original description
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)Read full original descriptionShow less
Randomized Study Comparing Negative Pressure Dressing Versus Conventional Dressing in Patients With Resected Limb or Trunk Soft Tissue Sarcoma (STS) After External Radiotherapy
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)
Inclusion: 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: Patient requiring a surgical revision after R1 or R2 resection; Planned no wound-closure and skin graft after resection; 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.