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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

Full criteria on ClinicalTrials.gov

Sites (15)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Institut de Cancérologie de l'Ouest - Pays de Loire
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AngersFranceRecruiting
Institut Bergonie
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BordeauxFranceRecruiting
CHRU Tours - Hopital Trousseau
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Chambray-lès-ToursFranceRecruiting
Centre Jean Perrin
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Clermont-FerrandFranceRecruiting
Centre Georges François Leclerc
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DijonFranceRecruiting
Centre Oscar Lambert
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LilleFranceRecruiting
CHU Limoges
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LimogesFranceRecruiting
Centre Leon Berard
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LyonFranceRecruiting
Institut du Cancer de Montpellier
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MontpellierFranceRecruiting
CHU Nantes
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NantesFranceRecruiting
APHP - Hôpital Cochin
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ParisFranceNot yet recruiting
Institut Curie
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ParisFranceNot yet recruiting
CHU Rennes
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RennesFranceNot yet recruiting
IUCT Oncopôle
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ToulouseFranceRecruiting
Institut de Cancérologie de Lorraine
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Vandœuvre-lès-NancyFranceNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.