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Clinical Trials in France / NCT05944913
Recruiting Not applicable

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

NCT05944913 · tracked via the Priya Life Science France tracker
Sponsor
Centre Leon Berard
Phase
Not applicable
Started
2023-08-03
Last updated
2025-08-08

Condition(s) studied

Soft Tissue Sarcoma

Investigational drug(s) / intervention(s)

Prevena

Prevena: PREVENA™ is a CE-marked class IIa medical device. The PREVENA™ Incision Management System is also intended to manage the environment of closed surgical incisions and surround intact skin in patients at risk for developing post-operative complications, such as infection, by maintaining a closed environment via the application of a negative pressure wound therapy system to the incision.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (15)

FacilityCityRegionStatus
CHU Nantes Nantes Pays de Loire Recruiting
Centre Leon Berard Lyon Rhône-Alpes Auvergne 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
Centre Georges François Leclerc Dijon France Recruiting
Centre Oscar Lambert Lille France Recruiting
CHU Limoges Limoges France Recruiting
Institut du Cancer de Montpellier Montpellier France Recruiting
Institut Curie Paris France Not Yet Recruiting
APHP Hôpital Cochin Paris France Not Yet Recruiting
CHU Rennes Rennes France Not Yet Recruiting
IUCT Oncopole Toulouse France Recruiting
Institut de Cancérologie de Lorraine Vandœuvre-lès-Nancy France Not Yet Recruiting

More Centre Leon Berard trials in France

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Adaptation Strategies for Coping With the Impact of Sensory Alterations on Eating Behavior in Children With Cancer: A Qualitative Study From the Perspective of Children and Parents Starting soon
Improved Management of Soft Tissue Sarcomas Patients With an Optimized and Innovative Sorting Technology for Circulating Tumor Cells Starting soon

Other trials for the same condition

Interest of Peri Operative CHemotherapy In Patients With CINSARC High-risk Localized Soft Tissue Sarcoma Recruiting
Efficacy and Safety of L19TNF in Previously Treated Patients with Advanced Stage or Metastatic Soft-tissue Sarcoma Active, not recruiting
A Study to Evaluate Pre-operative HYPOfractionated Radiation Therapy in Aged (≥ 70 Years Old) or "Fragile" (≥ 65 Years) Patients With Limb or Trunk Soft Tissue SARComa. Recruiting
Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With CRC, NSCLC, and STS Active, not recruiting
Multimodal Immune Characterization of RAre Soft Tissue Sarcoma - MIRAS Project From SARRA (SARcome RAre) Project of the French Sarcoma Group Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05944913 on ClinicalTrials.gov ↗ ← All trials in France